Konke mayelana ne-Cetilistat powder

 

  1.Yini i-Cetilistat powder
  I-2.Cetilistat powder i-powder eluhlaza Izinhlamvu eziyisisekelo
  I-3. Ingabe i-Cetilistat powder isebenza kahle
  Ukusetshenziswa kwe-4.Cetilistat powder
  5.Yini Isikali Nemijikelezo Ye-Cetilistat powder?
  6.Ziyini imiphumela emibi ye-Cetilistat powder?
  I-7. Iyini i-solubility ye-Cetilistat powder ku-solvents enhle?
  8. I-Cetilistat powder empeleni ingalahlekelwa isisindo?
  9.Isiphi i-Cetilistat powder isiza kanjani ngokulahlekelwa kwesisindo?
  10.Ingabe ukusebenzisa i-Cetilistat powder ukuphatha ukukhuluphala?
  I-11. Yiziphi izinyathelo ezikhethekile okumele zilandelwe ngenkathi kuthatha i-Cetilistat powder?
  12.Ufanele utshele udokotela wakho ngaphambi kokuthatha i-Cetilistat powder?
  13.Cetilistat powder Izixwayiso kanye nezixwayiso
  I-14.Ingabe ungadlulisa kanjani i-Cetilistat powder ibe yi-60mg yomlomo?
  I-15.Yimuphi umehluko we-Orlistat ne-Cetilistat powder?
  Luthini uhlelo Lokuthuthukiswa Kwesigaba III seCetilistat powder?
  I-17.Imibuzo ebuzwayo mayelana ne-Cetilistat powder

 


 

I-Cetilistat (i-Oblean) i-powder video

 

 


I.Cetilistat (Oblean) powder eziyisisekelo Abalingiswa:

 

Igama: I-Cetilistat (i-Oblean) powder
CAS:  282526-98-1
Ifomula Yamamolekhula: C25H39NO3
Isisindo Yamamolekhula: 316.31
I-Melt Point: I-190-200 ° C
Isitoreji Sokugcina: Ukushisa kwamakamelo
Umbala: Powder Grey

 


 

1. Yini i-Cetilistat powder?aasraw

 

I-Cetilistat powder yizinto eziphambili ze-Cetilistat powder, eyaziwa ngokuthi i-Cetislim, njalo isetshenziselwa ukwenza isisindo somkhiqizo, ukuphatha ukukhuluphala. okuyinto powder omhlophe nge CAS No. 282526-98-1.

 


 

2. Cetilistat powder Izinhlamvu eziyisisekelo:aasraw

 

Igama: I-Cetilistat powder, i-cetislim
CAS: 282526-98-1
Ifomula Yamamolekhula: C25H39NO3
Isisindo Yamamolekhula: 401.58
I-Melt Point: 72.0 kuya ku-76.0 ° C
Isitoreji Sokugcina: I-2-8 ℃
I-Cetilistat powder powder Umbala: I-white powder noma i-white powder

 


 

I-3. Ingabe i-Cetilistat powder isebenza kahle?aasraw

 

Ukusebenza komtholampilo nokuphepha kwe-Cetilistat powder kubonisiwe ochungechungeni lwezivivinyo zeSigaba II. Isivivinyo somtholampilo weSigaba IIb ezigulini ezingama-612 ezikhuluphele ngokweqile ezinesifo sikashukela sikhombise ukuthi esikhathini esingamaviki awu-12 sokwelashwa, i-Cetilistat powder 80mg ne-120mg ikhuthaze ukwehla kwesisindo okukhulu uma kuqhathaniswa ne-placebo (3.85kg no-4.32kg ngokuqhathaniswa no-2.86kg ngokulandelana), ngaleyo ndlela kuhlangatshezwane nenhloko yokuqala yecala iphuzu.

  • Akenzi ohlelweni lwesimiso esiphakathi;
  • Ukulwa nokukhuluphala;
  • Akuthathi isifiso sokudla;
  • Kuyasiza ukunciphisa isisindo nokuthuthukisa ukubunjwa komzimba;
  • Akubangela ukushintsha kwemizwelo njengokukhathazeka nokwesaba;
  • Ukusetshenziswa kwalo kukhishwa yi-ANVISA.


Indlela Yokukwazi Konke Kokukhanda Kwesiliva Le-Cetilistat Ukuze Ulahlekelwe Isisindo

 


 

4. Ukusebenzisa i-Cetilistat powderaasraw

 

powder Cetilistat (Cetislim) kuyinto imithi eqeda obesitiy esiza ukuthuthukisa kwesisindo ngu ezivimbela enzyme ebizwa ngokuthi lipase pancreatic. Le enzyme ifihliwe yi-pancreas futhi ngokuvamile isebenza ngaphakathi emathunjini lapho kusiza khona ukudiliza amafutha kanye ne-triglycerides. Ngokuvimbela umsebenzi wale enzyme, i-hydrolysis ye-triglycerides (izinhlobo zamafutha amabi) ivinjelwe kancane. Lokhu kubangela inani elincishisiwe elincane lamafutha e-acids mahhala namafutha ahlanganiswa emzimbeni, ikakhulukazi emva kokudla okunamafutha asetshenzisiwe.

Noma yikuphi amafutha angenayo i-undigested akakwazi ukufakwa futhi esikhundleni sakhe asuswa emzimbeni njengamafutha. Ukwelashwa kungasiza ekunciphiseni ama-visceral nama-bodyweight, nakuba iziguli kufanele ziqaphele ukuthi ukusetshenziswa kwemithi yokwelapha ngokweqile kudinga ukuhambisana nokudla, ukuzivocavoca kanye nezinye izinguquko zokuphila. Lokhu kuzokusiza ukunciphisa ingozi yokuthola izifo ezingelapheki ezihlobene nokuqhathanisa ngokweqile, njenge-2 yesifo sikashukela.

 


 

5. Siyini isilinganiso kanye nemijikelezo ye-Cetilistat powder?aasraw

 

I-Cetilistat powder dosage inikezwa njengama-capsules we-60mg amandla wokuphatha ngomlomo. Umuthi uthathwa ngokudla ukuqinisekisa ukuthi ungasebenza ngenkathi ukudla kugawulwa, ukuze ukunwa kwamanoni ekudleni kungancishiswe ngempumelelo. Udokotela wakho uzokutshela ukuthi kungakanani umuthi okufanele uthathe ngomthamo ngamunye, kanye nomthamo wansuku zonke odingekayo. Kubalulekile ukuthi unamathele kule miyalo. Ungathathi okungaphezu kwalokho udokotela wakho akutshela ukuthi uthathe.

I-Cetilistat Powder

Thenga ubumsulwa obuphezulu beTadalafil powder onlineZonke izinto okufanele uzazi !!! I-AASraw

 


 

6. Yimiphi imiphumela emibi ye-Cetilistat powder?aasraw

 

Iziguli ezithatha ukwelashwa ngokweqile ne-Cetislim (i-Cetilistat powder) i-powder ingaba nemiphumela emibi. Kumele utshele udokotela wakho uma lokhu kwenzeka. Ezinye izibonelo zinikwe lapha:

  • Amafutha esitokisini
  • I-cramp esiswini
  • Flatus ngokukhipha
  • Oily spotting
  • Ukungahambisani nomzimba
  • Flatulence
  • Ubuhlungu besisu
  • Uhudo
  • Izithambile ezithambile
  • Ukungqubuzana kwe-nasal
  • Ukuhlukunyezwa njalo
  • Ubuhlungu esiswini

Nakuba ukubhekwa okuncane kubhekwa njengokujwayelekile, izenzakalo ezimbi ezinzima zingase zenzeke. Xhumana nodokotela wakho ngokushesha uma lokhu kwenzeka.

 


 

I-7. Iyini i-solubility ye-Cetilistat powder ku-solvents enhle?aasraw

 

Ukuncibilika kwe-Cetilistat powder kuma-solvents ahlanzekile e-acetone, isopropanol, i-acetonitrile namanzi kunqunywe ngokuzanywa ngokusebenzisa indlela yokulinganisa yokuqothula isothermal ngaphakathi kwebanga lokushisa kusuka ku- (278.15 kuya ku-323.15) K ngaphansi kwengcindezi yomoya engu-101.1 kPa. Ekushiseni okuhleliwe, ukuncibilika kwengxenyana yemvukuzane ye-Cetilistat powder eluhlaza kwakukukhulu ku-acetone kunakwamanye ama-solvents amathathu acocekile. Babalwa njenge-acetone> isopropanol> acetonitrile> amanzi. Okutholwayo okutholakele bekuhambisana ne-Apelblat equation. Inani elikhulu kunawo wonke lokuphambuka okulinganiselwe kwaba yi-0.86 × 10− 2, nokuphambuka kwezimpande-kusho-isikwele, i-15.55 × 10− 4. Ngaphezu kwalokho, amapharamitha wokuzikhethela (δx1,3) we-Cetilistat powder kumxube we-acetone (1) + amanzi (2), isopropanol (1) + amanzi (2) kanye ne-acetonitrile (1) + amanzi (2) athathwe ezindaweni zawo ze-thermodynamic ngokusebenzisa indlela ephambene yokuhlanganiswa kweKirkwood-Buff. Amanani we-1,3x1 ahlukahlukene ngokungekho emgqeni nge-co-solvent (XNUMX) isilinganiso kuyo yonke imixube equkethe amanzi. Ipharamitha yokhetho lokuncanyelwa kwakukubi kumixube ecebile ngamanzi kepha yayinhle ekubunjweni okuphakathi nendawo kanye nemixube e-solvent-rich. Kulokhu kokugcina, bekucatshangwa ukuthi i-Cetilistat powder yayisebenza njenge-Lewis acid enama-molecule asebenzelana. Isenzo sokubambisana singahle sihlotshaniswe nokwephulwa kwesakhiwo samanzi esizungeze izinhlangothi ze-polar zeCetilistat powder eluhlaza okwandisa ukuxazululwa kwalesi sidakamizwa. Idatha encibilikayo kanye nesifundo se-thermodynamic sandise imininingwane ye-physicochemical mayelana ne-Cetilistat powder kumxube we-solvent kanambambili, obudingeka ezimbonini zemithi nezamakhemikhali ukonga isikhathi nemali ekusebenziseni inqubo yokwenziwa kwe-solubilization kanye / noma ye-crystallization process.

 


 

8. I-Cetilistat powder empeleni ingalahlekelwa isisindo?aasraw

 

Abacwaningi abaningana bathi i-Cetilistat powder tablet isebenza ukuvimbela ukumunwa kwamafutha. Umphumela wayo uhlaziywa ngokuyinhloko ngamanani amafutha avela emthonjeni wabantu ababelethwe izidakamizwa.

Ngo oshicilelwe kuyi-British Journal of yezemithi yokwelapha, izisebenzi zokuzithandela ezazibeka kwavele ukwelashwa nge Cetilistat powder eluhlaza zibonisa ukuthi lande eside fat endleni yabo uma kuqhathaniswa neqembu futhi akazange athathe izidakamizwa. Ucwaningo olufanayo lwaphetha ngokuthi ukwelashwa nge-Cetilistat powder kuyasebenza ukuvimbela ukumuncwa kwamathumbu emathunjini ezifundweni ezinempilo ezithola ukudla okulawulwayo.

Izivivinyo zokwelashwa ezenziwa yi-laboratory yaseJapane i-Takeda, umenzi we-Cetilistat powder eluhlaza wabonisa ukuthi abantu ababenakekelwa izidakamizwa ngezidakamizwa zamaviki e-12 balahlekelwa isisindo ngaphezu kwesigaba sokulawula esathola i-placebo kuphela.

Ucwaningo 612 iziguli okhuluphele, iqembu ethola Cetilistat powder at umthamo 120 mg kg 4: 32 elahlekile ngokwesilinganiso, kuyilapho iqembu wathola 80 MG Cetilistat powder eluhlaza iqedwe 3.85 kg. Iqembu lokulawula, elithola i-placebo kuphela elahlekile i-2.86 kg kumaviki angu-12.

Okungukuthi, kwakukhona ukulahlekelwa isisindo okungenani 25% ngaphezulu amaqembu usebenzisa Cetilistat powder kuqhathaniswa neqembu elalibhekwa zigcinwe ekudleni efanayo kodwa akatholanga umuthi.


Indlela yokusebenzisa i-Topiramate powder ye-Weight Loss AASraw Fat Loss

 


 

I-9. I-Cetilistat powder isisiza kanjani ngokulahlekelwa kwesisindo?aasraw

 

I-Cetilistat powder iyi- ukulahlekelwa kwesisindo isetshenziswa ngokuhlangana nokudla okuphansi kwekhalori. Isebenza ngokuvimba inani elikhulu lamafutha ekugayweni nasekungenisweni emzimbeni. Le powder yokulahlekelwa isisindo ihlukaniswa njenge-lipase inhibitor futhi isebenza ngqo ohlelweni lokugaya ukudla lapho ivimba khona isenzo se-enzyme ye-lipolytic ebizwa nge-lipase. La ma-lipases yiwona asetshenziswa ngumzimba ukugaya amanoni, kepha-ke, uma lo muthi ufakwa eceleni kwesidlo, ubopha ama-lipases, ngaleyo ndlela uwavimbele ekuhlukaniseni amafutha. Amafutha angafakwa i-hydrolyzed esikhundleni salokho akhishwa endleni, okuholela ekukhuphukeni kokukhishwa kwamafutha endle nokuncipha kokumunca amafutha. Uma isetshenziswa kanye nokudla okuncishisiwe kwekhalori, kungasiza ekuthuthukiseni ukuncipha komzimba futhi kwenze kube lula ngeziguli ezikhuluphele ukubuyela esimeni, ngaleyo ndlela kukhulise amathuba okuphumelela kwesisindo. Indlela yayo yokusebenzisa ifana ne- i-orlistat edala ngokuvimbela i-lipase ye-pancreatic.

 


 

10. Uyisebenzisa kanjani i-Cetilistat powder ukwelapha ukukhuluphala?aasraw

 

Ukukhula okukhulayo kokukhuluphala kuye kwashukumisa ukufuna izidakamizwa ukuphatha lesi simo. Kunezinqubo ezihlukahlukene zokwelapha eziye zahlolwa, kubandakanya:

  • I-Serotonin ne-noradrenaline reuptake inhibitors (ama-anorectic agents)
  • Lipase inhibitors
  • b Abakwa-3-adrenoreceptor agonists
  • Leptin agonists
  • Ama-agonists kaMelanocortin-3
  • Abaphikisi be-Endocannabinoid receptor

powder Cetilistat kuyinto inhibitor lipase, nge imodi efanayo ukuthatha isinyathelo esasiyobonisa ukuthi anti-ukukhuluphala imithi orlistat Roche sika (Xenical®) ethole imvume esemthethweni 1997. Lezi zidakamizwa zenza umuthi wokuvimbela amathumbu ukuvimbela i-lipase, ama-enzyme abandakanyeka ekudleni kwamafutha okudla. Ngokuvimbela ukuchithwa nokusabalalisa kwamafutha avela emathunjini, i-lipase inhibitors yenza ukunciphisa amafutha nama-kilojoule, ngaleyo ndlela kusiza ukulahlekelwa isisindo.

 


 

I-11. Yiziphi izinyathelo ezikhethekile okumele zilandelwe ngenkathi kuthatha i-Cetilistat powder?aasraw

 

  • Ungayeki ukuphuza imithi ngokungazelelwe ngaphandle kokuba ufundiswe udokotela. Ukuyeka imithi ngokuzumayo kungabangela ukugula ukubuyela.
  • Gwema ukusetshenziswa kotshwala ngoba kungashintsha ukumuncwa
  • Gcina imithi engeke ifinyelele izingane.
  • Ukwaziswa ukuthi ungathathi i-Cetilistat powder uma

idlulile usuku lokuphela komuthi onyatheliswe kulelo phakethe.
ukuphosa noma ukupakisha kubhidliziwe noma kubonisa izimpawu zokuphazamiseka noma ukubhujiswa.

 


 

I-12. Yini okufanele utshele udokotela wakho ngaphambi kokuthatha i-Cetilistat powder?aasraw

 

  • Yazisa udokotela uma unomlando wezenzo eziphikisayo nokusetshenziswa kwe
  • Tshela udokotela wakho uma ukhulelwa ngenkathi uthatha i-Cetilistat powder.
  • Yazisa udokotela uma uthatha noma yiziphi ezinye izidakamizwa, imithi ye-OTC, imikhiqizo yemithi noma izithako zokudla okunomsoco


Indlela Yokukwazi Konke Kokukhanda Kwesiliva Le-Cetilistat Ukuze Ulahlekelwe Isisindo

 


 

13. Izinyathelo Zokuqapha Nezexwayiso ze-Cetilistat powderaasraw

 

Akunconywa ukuthi uthathe amathisense angaphezulu kwe-3 phakathi kwamahora we-24.

Masinyane uye emnyangweni ophuthumayo oseduze nawe uma uthola ukubhekana nokugula. Izimpawu ezivame ukuhambisana nokuphendula okunjalo zihlanganisa ukucindezeleka ukuphefumula noma ukugwinya, ukuqina kwesifuba, ukuvuvukala, ukukhwabanisa isikhumba, kanye nezinyosi.

Cetislim akuzona njalo kufanelekile kuzo zonke iziguli. Njalo thintana nomhlinzeki wakho wokunakekelwa kwezempilo ngaphambi kokusebenzisa le mithi uma ukhulelwe, ukuncelisa, ukuzama ukukhulelwa, ukusebenzisa noma imiphi imithi (imithi noma imithi engekho imithi), usebenzisa noma yimaphi imikhiqizo noma imithi yokufakelwa kwemithi, noma uma unomsoco noma enye impilo izinkinga.

Isilinganiso esifanele se-Cetilistat powder kanye nemithi kadokotela ngokuvamile kuxhomeke esigulini kanye nesimo esiphathwayo. Ungalungisi umthamo wakho ngaphandle kwemvume yomhlinzeki wakho wezempilo. Lo mkhiqizo wukusetshenziswa kuphela njengoba kunqunywe futhi kufundiswe.

 


 

I-14. Ungadlulisa kanjani i-Cetilistat powder ibe ngamaphilisi omlomo 60mg?aasraw

 

I-Cetilistat powder iyakuthola Ifomu:

Amathuluzi wokugcwalisa i-02 # capsle 100mg / capsule I-Cetilistat powder 150g

I-Cetilistat powder dose: 60mg / umthamo

100mg / capsule-Cetilistat powder oluhlaza 60mg / dose = 40mg / dose isitashi sommbila

I-Cetilistat powder 60mg / umthamo: 40mg / dose isitashi sommbila = 3: 2

I-150g Cetilistat i-powder eluhlaza: 150mg isitashi se-corn = 3: 2

150g + 100g = 250g 250g = 250,000mg

250,000mg ÷ 100mg / capsule = 2500capsules (i-Cetilistat powder)

 


 

I-15. Uyini umehluko we-Orlistat ne-Cetilistat powder?aasraw

 

I-Cetilistat powder, i-novel emathunjini omzimba we-lipase inhibitor, ibonakala iphumelela ekulawuleni ukukhuluphala nokuncintisana kwayo njengenye i-lipase inhibitor, i-orlistat, ngenkathi kubonisa ukubekezelelana kangcono, ngokusho kwesigaba se-2 esihleliwe, esiphezulu, esiphansi, esibekwe yi-placebo, izifundo ze-12-ngesonto.

"Ukuvinjelwa kweLipase kufakazele ukusebenza kahle kweziguli ezikhuluphele kakhulu nasezigulini ezikhuluphele ezinesifo sikashukela," kusho uTom, umphathi, uphiko lwezempilo, iYunivesithi yase-East Anglia, eNorwich, e-United Kingdom, owethule lezi zifundo ezimbili egameni le-Cetilistat powder eluhlaza I-European Study Iqembu lapha e-15th European Congress on Obesity (ECO).

Ucwaningo lokuqala luphenye ukusetshenziswa kwe-Cetilistat powder ezigulini ezingama-372 ezikhuluphele ezinenkomba yomzimba (BMI)> 30, ezikhungweni kulo lonke elaseYurophu. Zonke iziguli zithole ukwelulekwa okunzulu nge-dietetic kulo lonke lolu cwaningo futhi zadla nokudla okunqunyiwe okwakubalwa ukuthi kungaba ama-kcals angama-500 ngaphansi kwesisindo sokugcina isisindo. Ngaphezu kwalokho, iziguli zanikezwa i-60, 120, noma i-240 mg ye-Cetilistat powder eluhlaza, noma i-placebo, ngezikhathi zokudla, kathathu nsuku zonke.

Ukwehla kwesisindo okuphawulekayo kufinyelelwe kuwo wonke amaqembu okwelashwa emasontweni ayi-12, ngokunciphisa isisindo esingu-3.5-kg ngesisindo esingu-120 mg Cetilistat powder kathathu nsuku zonke kuqhathaniswa ne-placebo (P <.05).

"I-Cetilistat powder yayisebenza ekunciphiseni ukulahleka kwesisindo emavikini angu-12 okutadisha," kusho uDkt Tom esethulweni ngo-Ephreli 23. "Ngaphezu kwalokho, kwehle kakhulu ukwehla kokhalo."

Esifundweni sesibili esakhishwa uDkt. Tom, abacwaningi babhalisa izihloko ze-612 obese zihlobo lwe-2 yesifo sikashukela, ababethatha i-metformin. Iziguli eziningi zazisemthethweni, futhi cishe ingxenye yesithathu nayo yayithatha imishanguzo ye-antihypertensive.

Njengokwalesi sifundo esedlule, iziguli zithole ukudla okunomqondo we-hypocaloric kanye nenye yezinhlobo ezintathu ezahlukene ze-Cetilistat powder eluhlaza (40, 80, noma i-120 mg), noma i-placebo. Ngaphezu kwalokho, iqembu lokufunda lesine lalingakahleleki ku-120 mg wama-orlistat izikhathi ezingu-3 nsuku zonke.

UDkt. Tom uthe ukunciphisa umzimba kunesisindo kuzo zonke izinhlangano zokwelapha, cishe cishe ezingu-35% zezifundo ezisezingeni eliphakeme kakhulu le-Cetilistat powder ekufezeni ukulahleka kwesisindo mayelana ne-5% yesisindo somzimba sokuqala noma ngaphezulu. Ngaphezu kwalokho, kunciphisa okubaluleke kakhulu kwe-hemoglobin ye-glycosilated (HbA1c) ngaphezulu kwamaviki angu-12.

Nakuba idatha ephumelelayo yayingalingani phakathi kwe-Cetilistat eluhlaza kanye ne-orlistat, ukungafani okukhulu kwavela phakathi kwalezi zidakamizwa ezimbili eziphathelene namaphrofayela abo okubekezela, kusho uDkt.

Sekukonke, iziguli eziphathwe nge-orlistat zazinezehlakalo ezimbi kakhulu eziphindwe kabili - ikakhulukazi emathunjini - okuholela ekuyekisweni kokwelapha kunase Iqembu le-Cetilistat powder. Izinga lezigameko ezimbi eziholela ekuqedeni ukulinganisa kwakufana phakathi kweqembu le-placebo nalabo abathola i-Cetilistat powder.

Ngenxa yalolu daba, uDkt. Tom waphetha ngokuthi i-Cetilistat powder eluhlaza inephrofayli enokubekezeleleka okuhle, futhi iphephile futhi iphumelele ekulawuleni ukukhuluphala nokuncipha kwayo.

Imali yalezi zifundo yanikezwa ngu I-AASraw Powder Powder, umenzi we-Cetilistat powder.


Ingabe usizo lwe-Synephrine powder lokulahlekelwa isisindo I-AASraw Fat Loss powder

 


 

16. Luyini uHlelo Lokuthuthukiswa Kwesigaba III se- I-Cetilistat powder ukulahlekelwa kwesisindo Powder?aasraw

 

ICambridge, UK - Mashi 6, 2008 - U-Alice (LSE: AZM) namuhla umemezela ukuthi i-FDA ivumile ngemithetho emibili esele yohlelo lwayo lokuthuthukiswa kweSigaba III seCetilistat powder ngaphansi kwenqubo ye-Special Protocol Assessment (“SPA”) futhi yancoma ukuthi u-Alice avule isifo sikashukela esihlukile i-IND.

I-Cetilistat powder

I-Cetilistat i-powder eluhlaza ingumkhiqizo ka-Alice osetshenziswayo wokwelashwa kokukhuluphala kanye nokugula okuhambisana nakho, kufaka phakathi uhlobo lwesifo sikashukela sohlobo 2. Kuyisilonda esiswini se-lipase inhibitor esivimba ukugayeka kwamafutha kanye nokumuncwa, okuholela ekwehlisweni kokudla kwamandla, futhi ngaleyo ndlela kwehle isisindo.

Ukulandela ukucubungula okuphumelelayo kwezingxoxo zeSigaba II, uhlelo lwe-FDA olwamukelwe uhlelo luka-Alice lwe-Phase III yokuthuthukiswa kwemitholampilo yeCelitilistat powder. Lokhu kuqukethe izifundo ezintathu ze-12 zenyanga ezibandakanya:

(i) iziguli eziningi kakhulu ezingenayo i-co-morbidity kanye neziguli ezitholakalayo ezinama-co-morbidity (ngaphandle kohlobo lwe-2 yesifo sikashukela);

(ii) iziguli ezitholakale zingenayo i-co-morbidity kanye neziguli ezingaphezu kwamandla okungahlosiwe (ngaphandle kohlobo lwe-2 sikashukela); futhi

(iii) kuneziguli ezinesifo sikashukela sohlobo lwe-2 futhi okungenzeka ukuthi siphathe noma saphatha kabi ezinye izifo.

Ngo-Ephreli 2007, u-Alice wamemezela ukuthi umthetho olandelwayo ocwaningweni lokuqala kwavunyelwana ngawo ne-FDA ngaphansi kwenqubo ye-SPA. Izivumelwano zesifundo sesibili nesesithathu manje sekuvunyelwene ngazo ne-FDA ngaphansi kwenqubo ye-SPA. Isifundo sesibili sizobandakanya ukuqhathanisa okuqondile neXenical ®, kanye ne-placebo.

I-FDA ikhishwe isiqondiso sokusungula ekuthuthukiseni izidakamizwa zesifo sikashukela ekupheleni kukaFebhuwari 2008. Ngaphansi kwalesi siqondiso, uye wavuma ukuthi ukuthuthukiswa ku-HbA1c sekube ngumphumela wokulinganisa ojwayelekile wesilinganiso sikashukela.

Ubufakazi bokuphepha nokusebenza kwe-Cetilistat powder eluhlaza kusungulwe ngezifundo eziningi zeSigaba I kanye neSigaba II. Ngaphezu kwalokho, ezifundweni zeSigaba II, i-Cetilistat i-powder eluhlaza yaboniswa ukuthi ibangele ukwehla kwesisindo okuphawulekayo, uma kuqhathaniswa ne-placebo futhi, ezigulini ezinesifo sikashukela okhuluphele ngokweqile, ukudala ukuncipha okuphawulekayo kwe-HbA1c.

 

Indlela Yokukwazi Konke Kokukhanda Kwesiliva Le-Cetilistat Ukuze Ulahlekelwe Isisindo

 

I-FDA ibhalelene ngqo no-Alice maqondana nohlelo lwayo oluhleliwe lweSigaba III futhi yancoma ukuthi u-Alice avule i-IND ehlukile yesifo sikashukela se-Cetilistat powder, ngoba manje akusadingi ukuthi umthelela wezidakamizwa ekulawuleni i-glycemic uzimele ngomthelela wawo esisindweni somzimba ukuze ukuze lo muthi ubhekelwe ukuthi uzimele wedwa ushukela. Yize i-FDA isho esidlangalaleni ukuthi izifundo zokuphepha zesikhathi eside ezingahlala isikhathi esingaphezu konyaka zingadingeka kwezinye izindlela zokwelapha lapho kuvela khona izindaba ezinkulu zokuphepha noma imibuzo, kukhombisile ukuthi isifundo sezinyanga eziyi-12 sizokwanela isifundo esibaluleke kakhulu neCetilistat powder eluhlaza kwabanesifo sikashukela abakhuluphele.

Uhlelo lwe-Phase III lokuthuthukiswa kwe-Cetilistat powder, olunikeza indlela ecacile yokubhalisa njengomkhiqizo wokukhuluphala, manje usulungele ukuqala ukulandela isiphetho se-commercial deal. Kulokhu kube nokubaluleka okubambisana kanye nentuthuko e-Cetilistat eluhlaza powder; izingxoxo ziyaqhubeka.

Ekhuluma ngesimemezelo, isikhulu esiPhezulu esiPhezulu, uTim McCarthy wathi:

“Ziyangijabulisa lezi zindaba. Akuyona kuphela indlela elawula i-Cetilistat powder njengomkhiqizo wokukhuluphala osungulwe ngokuqinile ne-FDA, enikeza ukucaciseleka kwabalingani abangaba khona maqondana nomzila wokumaketha i-Cetilistat powder oluluhlaza, kepha nethuba lokuthuthukisa imakethe yeCetilistat powder ngokuqhubeka ngokuvula i-IND ngesifo sikashukela kubaluleke kakhulu kwezohwebo. ”

Uhlelo Lokuhlola Olukhethekile Lokusebenza (SPA)
Ngokubambisana nokugunyazwa kabusha komthetho we-Prescription Drug User Fee we-1992 (PDUFA) ngoNovemba 1997, i-FDA yavumelana nemigomo ethile yokusebenza yokuhlola nokuvumelanisa okukhethekile. Lezi zinhloso zihlinzeka ngokuthi, uma isicelo, i-FDA izohlola izivumelwano ezithile (okungukuthi izinqubo zokudla kwamagciwane, izinyathelo zokuzinza, kanye nezigaba ze-Phase III zokuhlolwa kwezempilo ezizokwenza isisekelo esiyinhloko sesimangalo esisebenzayo) ukuhlola ukuthi zanele yini ukuhlangabezana nesayensi nokulawula izidingo ezikhonjwe ngumxhasi (kulolu cala Alice).

Uma i-FDA kanye nomncintiswano oxhasayo, ngaphansi kwe-Special Protocol Assessment, i-Arhente ibhala isivumelwano sokuthi ukuklama nokuhlaziywa okuhleliwe kwesifundo kuhlose ngokwanele izinhloso zokusekela ukuhanjiswa okulawulwayo.

Njengoba kuboniswe imigomo ye-PDUFA ye-Special Protocol Assessment, njengoba ivumile ukuklanywa, ukukwenziwa, nokuhlaziya okuhlongozwayo kumaphrothokithi abuyekezwa ngaphansi kwalolu hlelo, i-Agency ngeke iguqule umbono wayo ngokuphathelene nokuklama, ukukwenziwa, noma ukuhlaziywa ngaphandle kokuthi impilo yomphakathi ukukhathazeka okungaqondakali ngesikhathi sokuhlolwa kweprotocol ngaphansi kwalolu hlelo kubonakala.

Faka ikhofi eluhlaza

Umkhiqizo ka-Alice we-metabolic, i-Cetilistat powder, wenzelwe ukwelapha ukukhuluphala kanye nokugula okuhambisana nakho (okubandakanya uhlobo lwesifo sikashukela sohlobo 2). Kuyisilonda esiswini se-lipase inhibitor esivimba ukugayeka kwamafutha kanye nokumuncwa, okuholela ekwehlisweni kokudla kwamandla, futhi ngaleyo ndlela kwehle isisindo. Ihlukile kwamanye amanxusa amaningi wokulwa nokukhuluphala ngoba ayisebenzi ebuchosheni ukunciphisa isifiso sokudla, kepha isebenza ngokuningiliziwe. Isakhi sihlala emgodini wamathumbu kungekho ukumuncwa okuphawulekayo emzimbeni. Ngakho-ke, kungalindelwa ukuthi kube nephrofayili ephezulu yenzuzo yezidakamizwa ezisebenza maphakathi. Ngakho-ke, i-Cetilistat i-powder eluhlaza ayihambisani nezinkinga zokuphepha ngokuvamile ezihambisana nezidakamizwa ezisebenza maphakathi nendawo.

I-Roche's Xenical ingumkhiqizo wokukhuluphala ovunyelwe futhi ibuye ibe i-lipase inhibitor eseceleni. Kodwa-ke, ezivivinyweni zomtholampilo, i-Cetilistat powder iboniswe ukuthi ibekezelelwe kangcono kune-Xenical enemiphumela engemihle ethinta kabi ukuhambisana kweziguli.

 


 

I-17. Imibuzo evame ukubuzwa mayelana I-Cetilistat powder impahla eluhlaza Powderaasraw

 

A. Ingabe kuphephile ukushintsha umthamo we-powder Cetilistat?
Cha, akusiluleka ukushintsha umthamo owunqunyiwe. Xhumana nodokotela wakho ngemibuzo ephathelene nomthamo.

B. Kungokwemvelo ukuzwa u-flatulence ne-Cetilistat powder eluhlaza?
Yebo, flatulence kuyinto Cetilistat powder imiphumela emibi. Nokho, thintana nodokotela wakho.

C. Ngingayincoma yini le mithi kwabanye?
Akunakucelwa ukuncoma izidakamizwa kwabanye njengoba ubuhlungu besimo kanye nomlando wezokwelapha akufani naso sonke umuntu.

 

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