Pharmacokinetics and Bioequivalence of Fluconazole Capsules Manufactured in France and China in Healthy Chinese Participants: Open‐Label, Randomized, Single‐Dose, 2‐Way, Crossover Bioequivalence Study Under Fasted and Fed Conditions

Abstract

AbstractThis was an open‐label, randomized study in healthy Chinese participants to assess the bioequivalence of 2 fluconazole 150‐mg capsules under fasted and fed conditions. The study consisted of 2 treatment periods, separated by a 14‐day washout period. Thirty‐six participants were enrolled, with 18 participants each in the fasted and fed groups. In each treatment period, participants received a single oral dose of the test or reference fluconazole 150‐mg capsule. After washout, participants received the alternate treatment. Blood samples for pharmacokinetic analysis were collected from 1 hour before dosing to 72 hours after dosing. The median plasma concentration–time profiles were similar for both treatments under fasted and fed conditions. Bioequivalence of fluconazole between the 2 capsules was demonstrated as 90% confidence intervals of the geometric mean ratios for the maximum plasma concentration and area under the plasma concentration–time curve from time 0 to 72 hours after dosing under fasted and fed conditions were within the acceptable range of 80%–125%. Overall, 7 participants reported at least 1 treatment‐emergent adverse event; all were mild in severity. No serious adverse events or deaths were reported. The test fluconazole capsule was bioequivalent to the reference capsule, and a single dose was well tolerated.Clinicaltrials.gov ID: NCT03621072