Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers.
The objective of this study was to assess bioequivalence of 500-mg clarithromycin tablets in 24 healthy volunteers. In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500-mg clarithromycin tablet. Plasma samples were collected over a 24-h period after administration and were analyzed by using a validated method using high performance liquid chromatography (HPLC) with electrochemical detection. The time to reach the maximal concentration (t(max),h), the peak concentration (C(max),ng/ml) and the area under the curve (AUC(0- infinity),ng h/ml) of the Reference and Test formulations were 2.1+/-0.7 vs 2.1+/-0.7, 2474+/-702 vs 2559+/-744 and 15803+/-6120 vs 17683+/-6650, respectively. Relative bioavailability was 1.12. The 90% confidence interval (90% CI) of C(max) and AUC(0- infinity) were 95.6-110.8% and 3.5-122.0%, respectively. Bioequivalence between the test and reference preparation can be concluded.
Lohitnavy
Ornrat
O
Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok 65000, Thailand. ornratl@hotmail.com
Lohitnavy
Manupat
M
Sareekan
Kannika
K
Polnok
Sanglar
S
Taytiwat
Prawit
P
D017291:Clarithromycin / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets / Q000008:administration & dosage; D013785:Thailand; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D013607:Tablets; D017291:Clarithromycin