A Randomized Trial in Healthy Subjects to Assess the Bioequivalence of an Atazanavir/Cobicistat Fixed-Dose Combination Tablet versus Administration as Separate Agents
| العنوان: | A Randomized Trial in Healthy Subjects to Assess the Bioequivalence of an Atazanavir/Cobicistat Fixed-Dose Combination Tablet versus Administration as Separate Agents |
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| المؤلفون: | Heather Sevinsky, Palanikumar Ravindran, Richard Bertz, K. Sims, Navin Jariwala, Xiaolu Tao, Xiaohui Xu, Reena Wang |
| المصدر: | Antiviral Therapy. 20:493-500 |
| بيانات النشر: | SAGE Publications, 2014. |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | Adult, Male, Adolescent, Atazanavir Sulfate, Fixed-dose combination, Administration, Oral, Biological Availability, ATAZANAVIR/COBICISTAT, HIV Infections, Bioequivalence, Pharmacology, law.invention, Young Adult, Randomized controlled trial, law, medicine, Humans, Pharmacology (medical), Cross-Over Studies, business.industry, Healthy subjects, HIV Protease Inhibitors, Middle Aged, Crossover study, Healthy Volunteers, Atazanavir, Drug Combinations, Infectious Diseases, Therapeutic Equivalency, Cytochrome P-450 CYP3A Inhibitors, Cobicistat, Drug Therapy, Combination, Female, Ritonavir, business, human activities, medicine.drug |
| الوصف: | Background Cobicistat (COBI) is an alternative pharmacoenhancer to ritonavir. A fixed-dose combination (FDC) tablet containing atazanavir (ATV) and COBI has been developed for the treatment of HIV-1-infected patients. Methods This open-label, single-centre, single-dose, crossover study, randomized 64 healthy subjects to one of eight treatment sequences. Under light meal conditions, maximum plasma concentration (Cmax), area under the plasma concentration–time curve (AUC) to infinity (AUCINF) and AUC to the last measurable concentration (AUC0–T) for ATV and COBI administered as an FDC of ATV/ COBI (300/150 mg) were compared to those following administration as separate agents given together; bio-equivalence was concluded if the 90% CIs of the geometric mean ratios fell within the predetermined range of 0.80, 1.25. ATV and COBI pharmacokinetic parameters following administration as the FDC or as separate agents were also compared under fasted conditions. The effect of food (light and high-fat meals) on the pharmacokinetics of ATV and COBI for the FDC was also assessed. Results ATV and COBI administered in an FDC tablet were bioequivalent to the individual agents when given with a light meal. Under fasted conditions, pharmacokinetic parameters for ATV and COBI were similar for the individual components and the FDC. For the FDC, systemic exposure to ATV increased with a light meal compared to fasted conditions, and ATV concentration 24 h post-dose was similar with a light meal compared with a high-fat meal. Conclusions ATV/COBI (300/150 mg) FDC tablet was bio-equivalent to coadministration as separate agents with a light meal in healthy subjects. Clinicaltrials.gov identifier NCT01837719. |
| تدمد: | 2040-2058 1359-6535 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::16454de5b7663755e0d0d550869f5cee https://doi.org/10.3851/imp2913 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....16454de5b7663755e0d0d550869f5cee |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20402058 13596535 |
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