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This 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 [ABSTRACT FROM AUTHOR]

Azithromycin (Zithromax) is an azalide antibiotic that binds to the 50S ribosomal subunit of the susceptible organism and thereby interferes with its protein synthesis. An open‐label, randomized, single‐dose, 3‐way crossover bioequivalence study was conducted to compare the rate and extent of absorption of the azithromycin 250‐mg tablet manufactured at Pfizer Dalian (China) and that at Pfizer Barceloneta (United States) under fasted and fed conditions in healthy Chinese subjects. This study aimed to support a generic consistency evaluation program, initiated by the National Medical Products Administration, for evaluating the quality and efficacy of the products manufactured in China. In the study, the within‐subject standard deviation for area under the serum concentration–time profile from time 0 to 72 hours after dosing in the fasted condition was <0.294, and the 90%CI for the ratio was within 80% to 125%; the within‐subject SDs for serum peak concentration in the fasted condition, area under the serum concentration–time profile from time 0 to 72 hours after dosing in the fed condition, and serum peak concentration in the fed condition, were all >0.294, with the upper confidence bounds being <0.00, and the point estimates of the ratios being within 80% to 125%. The results support the bioequivalence between azithromycin tablets manufactured in China and the United States in fasted and fed conditions, with both tablets showing an acceptable safety/tolerability profile in the studied population. [ABSTRACT FROM AUTHOR]