Average bioequivalence of generic clarithromycin tablets in healthy thai male volunteers
- 6 June 2003
- journal article
- clinical trial
- Published by Wiley in Biopharmaceutics & Drug Disposition
- Vol. 24 (6), 229-231
- https://doi.org/10.1002/bdd.341
Abstract
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 (tmax,h), the peak concentration (Cmax,ng/ml) and the area under the curve (AUC0–∞,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 Cmax and AUC0–∞ were 95.6–110.8% and 3.5–122.0%, respectively. Bioequivalence between the test and reference preparation can be concluded. Copyright © 2003 John Wiley & Sons, Ltd.Keywords
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