Average bioequivalence study of clarithromycin tablets in healthy male volunteers.
OBJECTIVE
To evaluate the average bioequivalence of two formulations of 500 mg clarithromycin tablets in 24 healthy Thai male volunteers.


METHODS
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 analysed by using a validated HPLC-ECD method. Pharmacokinetic parameters were determined by using non-compartmental analysis.


RESULTS
The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL) and the area under the curve (AUC0- infinity, ng h/mL) of the Reference and Test formulations were 2.0 +/- 0.9 vs. 1.8 +/- 1.1, 3018 +/- 841 vs. 3014 +/- 752 and 23142 +/- 7348 vs. 22810 +/- 6027, respectively. The 90% confidence interval of Cmax and AUC0- infinity were 90.6-109.4 and 89.6-110.1%.


CONCLUSIONS
Bioequivalence between the Test and Reference formulation can be concluded.
Lohitnavy
M
M
Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. manupatl@hotmail.com
Lohitnavy
O
O
Sareekan
K
K
Chaiyaput
W
W
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D017291:Clarithromycin / Q000097:blood / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency
D000900:Anti-Bacterial Agents; D013607:Tablets; D017291:Clarithromycin