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

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 saf...