Bioequivalence Analysis of Clindamycin Hydrochloride Capsules in Healthy Chinese Subjects Under Fasted and Fed Conditions

• Published in: Clinical pharmacology in drug development Vol. 14; no. 2; p. 127
• Main Authors: Wang, Zhi, Wen, Haitang, Qian, Xuebing, Huang, Min, Cheng, Guohua, Zhong, Guoping
• Format: Journal Article
• Language: English
• Published: United States 01.02.2025
• Subjects: Administration, Oral; Adult; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - blood; Anti-Bacterial Agents - pharmacokinetics; Area Under Curve; Capsules; Chromatography, High Pressure Liquid; Clindamycin - administration & dosage; Clindamycin - adverse effects; Clindamycin - blood; Clindamycin - pharmacokinetics; Cross-Over Studies; East Asian People; Fasting - blood; Female; Food-Drug Interactions; Healthy Volunteers; Humans; Male; Tandem Mass Spectrometry; Therapeutic Equivalency; Young Adult; fasted; fed; clindamycin; bioequivalence; healthy Chinese subjects
• ISSN: 2160-7648
• DOI: 10.1002/cpdd.1480

Clindamycin is a lincosamide antibiotic for the treatment of staphylococcal, streptococcal, and anaerobic bacterial infections. We conducted a single-center, single-dose, 2-preparation, 2-period, 2-sequence, randomized, open-label, 2 × 2 crossover study to evaluate the pharmacokinetics (PKs) and safety of the test and reference clindamycin hydrochloride capsules in healthy Chinese subjects under both fasted and fed conditions. Forty-eight subjects were enrolled in the study totally, with 24 subjects in each group. All subjects were asked to take a test or reference preparation, under either fasted or fed condition, and their blood samples were collected and assayed by a validated high-performance liquid chromatography-tandem mass spectrometry method. PK parameters including maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last concentration, and area under the plasma concentration-time curve from time 0 to infinity were estimated with noncompartmental model and analyzed. Results showed that the PK profiles of the 2 preparations were consistent and met the bioequivalence criteria. Food was identified as a factor that had an impact on clindamycin absorption. The safety of clindamycin hydrochloride capsules was satisfactory. This study proved that the 2 clindamycin hydrochloride capsules were bioequivalent in healthy Chinese subjects under both fasted and fed conditions.