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- Title
Effects of a Nutritional Protein‐Rich Drink on the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide, and Tenofovir Compared With a Standard Meal in Healthy Japanese Male Subjects.
- Authors
Yamada, Hiroyuki; Ikushima, Ippei; Nemoto, Takanori; Ishikawa, Tomohiro; Ninomiya, Noriko; Irie, Shin
- Abstract
Abstract: This study investigated the effects of ingested meal types on the pharmacokinetics of elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir alafenamide (TAF), and tenofovir (TFV) following a single administration of the single‐tablet regimen (STR) of EVG/COBI/FTC/TAF (150/150/200/10 mg) in Japanese HIV‐negative healthy subjects (n = 12). In this open‐label, randomized, 3‐way crossover study, the bioequivalence of the EVG/COBI/FTC/TAF STR following ingestion of a nutritional protein‐rich drink with a reference treatment of taking a standard breakfast was evaluated. Administration under fasted conditions, no food intake, resulted in decreases in the mean AUCinf and Cmax of EVG by 50% and 57%, respectively, relative to the administration with a standard breakfast, whereas the systemic exposure of EVG with a nutritional protein‐rich drink was comparable to that with a standard breakfast. The mean AUCinf and Cmax of COBI, FTC, TAF, and TFV were comparable regardless of meal intake or meal types. Although the package insert of the EVG/COBI/FTC/TAF STR states that the medication is recommended to be taken with food, this study provides an additional insight into HIV‐1‐infected patients that a light meal like a nutritional protein‐rich drink can be an alternative to a standard meal.
- Subjects
PHARMACOKINETICS; EMTRICITABINE; TENOFOVIR; DRUG administration; DRUG tablets; INGESTION
- Publication
Clinical Pharmacology in Drug Development, 2018, Vol 7, Issue 2, p132
- ISSN
2160-763X
- Publication type
Article
- DOI
10.1002/cpdd.365