Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation

The study was conducted to investigate the pharmacokinetics and relative bi oavailability of clindamycin after administration of two oral clindamycin H Cl formulations. A new tablet preparation containing 600 mg clindamycin (Cl inda-saar 600, test) was compared to a marketed capsule containing 300 mg c lindamycin (Sobelin 300, reference). Both preparations revealed comparable in vitro dissolution profiles with high batch conformity and homogeneity. T wenty healthy male volunteers received single doses of 600 mg clindamycin ( test: 1 tablet, reference: 2 capsules) in an open, randomized, two-period c rossover design. Blood samples were drawn up to 14 h p.a. and clindamycin p lasma concentrations were measured using a sensitive and specific HPLC-UV m ethod. Pharmacokinetic characteristics were similar for both preparations, arithmetic mean values (standard deviation) were computed as: AUC(0-infinit y) 12.2 (4.2) and 13.1 (4.6) mu gxh/ml, C-max 3.1 (0.8) and 3.4 (0.8) mu g/ ml, t(max) 0.83 (0.24) and 0.85 (0.34) h, t(1/2) 2.3 (0.4) and 2.3 (0.6) h for test and reference, respectively. Mean relative bioavailability (point estimate) was 93% for AUC and 91% for C-max. 90% confidence intervals for A UC and C-max were within the predefined bioequivalence acceptance limits. B ioequivalence of test and reference preparations could be demonstrated. Sin gle doses of 600 mg clindamycin orally were well tolerated without relevant differences between both preparations.