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This study aimed to determine the bioequivalence of Azithromycin tablets 500 mg manufactured by ACI HealthCare Limited and ZITHROMAX® (azithromycin) tablets 500 mg from Pfizer Labs Division of Pfizer Inc.It was a randomized, double-blind crossover trial conducted at Raptim Research Pvt. Ltd., India, involving healthy adult male subjects in both fasting and fed conditions.Key pharmacokinetic parameters, including Cmax and AUC0-t, were evaluated.The 90% confidence intervals for the ratio of geometric least square means based on Ln-transformed primary PK parameters were as follows: 1) Cmax (fasting: 91.33-104.86,fed: 89.64 -109.64) 2) AUC0-t (fasting: 93.13-102.76,fed: 90.97-104.79)3) AUC0-inf (fasting: 93.37-102.67,fed: 90.70-105.00).These intervals were found within the acceptable bioequivalence limits of 80.00% to 125.00% for Azithromycin.The study observed a maximum intra-subject coefficient of variation (ISCV) of 27.42% for Cmax.Based on this ISCV and a ratio estimate (Test/Reference) of 93-107%, a sample size of 64 subjects (including a 10% dropout rate) was calculated as sufficient for the study design.The results indicated that Azithromycin tablets 500 mg from ACI HealthCare Limited were bioequivalent to ZITHROMAX® tablets 500 mg under fed conditions.
Alam et al. (Fri,) studied this question.