Pharmacokinetics and safety comparison of cycloserine capsules and their generic counterpart: a randomized, open-label, two-period, two-sequence, single-dose crossover bioequivalence study in healthy Chinese subjects

Introduction Cycloserine is a broad‐spectrum antibiotic and clinically important second‐line anti‐tuberculosis agent. This study assessed the bioequivalence of a test cycloserine formulation versus its reference formulation under fasted and fed conditions. Methods Using a randomized, open‐label, two‐period, two‐sequence crossover design, 64 healthy Chinese participants were enrolled (63 completed). Subjects received a single 250‐mg oral dose of both formulations. Bioequivalence was evaluated using plasma concentration‐time profiles and key pharmacokinetic (PK) parameters. Statistical analysis employed the Average Bioequivalence (ABE) method. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for C max , AUC 0‐t and AUC 0‐∞ fell entirely within the predefined range (80.00–125.00%) under both conditions. Results Both formulations exhibited comparable safety profiles. Discussion Bioequivalence was established between the test and reference cycloserine capsules under fasted and fed states. Clinical Trial Registration Chinese Clinical Trial Registry ( www.chinadrugtrials.org.cn ) as (CTR20233940).