A Bioequivalence Study of Avanafil in Healthy Chinese Male Subjects Under Fasting and Fed Conditions: Results of a Randomized, Open-Label, Single-Dose, 2-Sequence, 2-Period Crossover Study.

ABSTRACT: This bioequivalence study was conducted to determine the pharmacokinetics and safety profiles of an originator and a generic avanafil formulation in Chinese male subjects under fed and fasting conditions. Each eligible subject was initially randomly given avanafil (200 mg) in a test-reference or reference-test order, before being switched to another study drug sequence after 7 drug-free days. The bioequivalence of test and reference avanafil were determined if the 90%CIs of the geometric mean ratio (GMR) for the area under plasma concentration-time curve (AUC) from time 0 to infinity (AUC_0-∞ ), AUC from time 0 to the last detectable concentration (AUC_0-t ), and the maximum plasma concentration (C_max ) fell within the range 80%-125%. Under fasting/fed condit

SUBMITTER: Ren X 

PROVIDER: S-EPMC9291160 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature