Average bioequivalence of generic clarithromycin tablets in healthy thai male volunteers
| Autor: | Prawit Taytiwat, Sanglar Polnok, Kannika Sareekan, Ornrat Lohitnavy, Manupat Lohitnavy |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Male
Pharmacology Chromatography business.industry Area under the curve Pharmaceutical Science General Medicine Bioequivalence Thailand Crossover study Bioavailability Therapeutic Equivalency Pharmacokinetics Clarithromycin medicine Drugs Generic Humans Pharmacology (medical) business Volunteer Tablets Antibacterial agent medicine.drug |
| Zdroj: | Biopharmaceutics & Drug Disposition. 24:229-231 |
| ISSN: | 1099-081X 0142-2782 |
| DOI: | 10.1002/bdd.341 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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