Pharmacokinetics, Safety and Bioequivalence Study of a Single Dose of Two Azithromycin Granules Administered under Fasting and Fed Conditions in Healthy Chinese Volunteers
Year: 2026
Type: preprint
Abstract: Purpose This study aimed to evaluate the pharmacokinetics, safety, and bioequivalence of test and reference Azithromycin granules in healthy Chinese volunteers under fasting and fed conditions. Methods This single-center, randomized, open-label, single-dose, 2-period, 2-sequence crossover study enrolled 108 participants. Participants received a 500-mg dose of either formulation under fasting conditions (n = 40) or fed conditions (n = 68), with a 21-day washout. Plasma Azithromycin concentrations were quantified using liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were calculated noncompartmentally. Bioequivalence was evaluated using 90% confidence intervals (CIs) for test-to-reference geometric mean ratios (GMRs) of C max , AUC 0−t , and AUC 0−∞ . Results Under fasting conditions, GMRs (90% CIs) were 107.07% (99.66%-115.04%) for C max , 102.46% (96.62%-108.65%) for AUC 0−t , and 104.35% (97.95%-111.18%) for AUC 0−∞ . Under fed conditions, values were 102.00% (93.82%-110.91%), 95.00% (88.20%-102.32%), and 96.28% (90.19%-102.79%), respectively. All CIs were within the range of 80.00%-125.00%. One serious adverse event in the fed group (ectopic pregnancy) was assessed as not related to the study drug. No drug-related serious adverse events were observed under fasting or fed condition. Conclusion The test and reference Azithromycin granule formulations met bioequivalence criteria under both fasting and fed conditions. No drug-related serious adverse events were identified in this study. Trial registration The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2300074532; August 9, 2023)
Source: Research Square
Language: English
Subfield: Pharmacology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225737790