Fed-Fasted Differences in Clindamycin Hydrochloride Capsule Pharmacokinetics: A Pooled Analysis of Publicly Available China CDE Regulatory Summaries.

We evaluated food-associated differences in clindamycin hydrochloride capsule exposure by pooling publicly available regulatory bioequivalence (BE) summaries from the Center for Drug Evaluation of the National Medical Products Administration in China. Fourteen candidate regulatory identifiers were reviewed; one 0.15-g BE-exempt record without analyzable pharmacokinetic (PK) data was excluded, leaving 13 records (ten 150 mg and three 300 mg). CYHB1901758 and CYHB2140526 were treated as independent 300-mg BE records under the authors' prespecified working assumption. For each record and endpoint, test and reference formulation fed/fasted ratios were combined on the log scale, and regulatory records were pooled with equal weight. For the 150-mg strength, pooled fed/fasted geometric mean ratios (GMRs) [95% descriptive interval] were 1.31 [1.24, 1.38] for AUC0-t, 1.30 [1.23, 1.38] for AUC0-inf, and 0.85 [0.80, 0.90] for Cmax. For the 300-mg strength, the corresponding GMRs were 1.17 [0.92, 1.50], 1.19 [0.93, 1.52], and 0.93 [0.88, 0.97]. Thus, the available aggregate summaries showed higher total exposure and lower peak concentration under fed conditions, particularly for the 150-mg strength. These findings describe a food-associated PK pattern but do not constitute a formal regulatory food-effect assessment or support a change in meal-timing recommendations.