Comparative bioavailability of clarithromycin formulations in healthy brazilian volunteers
| Autor: | E. Abib-Junior, R. A. Moreno, R. P. Simoes, Pedro Luiz Rosalen, Sinvaldo Baglie, Luiz Madaleno Franco, Francisco Carlos Groppo, Ana Paula Del Bortolo Ruenis, Gilson Cesar Nobre Franco |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Adolescent Coefficient of variation Administration Oral Biological Availability Pharmacology Bioequivalence Animal science Clarithromycin Healthy volunteers medicine Humans Pharmacology (medical) Cross-Over Studies business.industry Clarithromycin 500 MG Middle Aged Crossover study Bioavailability Anti-Bacterial Agents Area Under Curve Female Geometric mean business Brazil medicine.drug Tablets |
| Zdroj: | International journal of clinical pharmacology and therapeutics. 43(8) |
| ISSN: | 0946-1965 |
| Popis: | Objective: To compare the bioavailability of clarithromycin 500 mg tablets (Merck S.A Industrias Quimicas, Sao Paulo, SP, Brazil, used as test formulation) and Klaricid® (Abbott LaboratOrios do Brasil Ltda, Sao Paulo, SP, Brazil, used as reference formulation) in 24 healthy volunteers. Material and methods: The study was conducted using an open, randomized, two-period crossover design with one-week interval between doses. Blood samples were collected at pre-dose, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3,4, 6, 8, 10, 12, 16, 20 and 24 hours after the administration. AUC was calculated by the trapezoidal rule extrapolation method. C m a x and t m a x were compiled from the plasmatic concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC 0 - i n f , AUC 0 - 2 4 h , C m a x and untransformed t m a x . Results: Intraindividual coefficient of variation (CV%) values were 14.25% and 12.62%, respectively for C m a x and AUC 0 - 2 4 h . The geometric mean values (′ SD) for AUC 0 - 2 4 h (μg × h/ml), AUC 0 - i n f (μg × h/ml), and C m a x (μg/ml) for test medication were 18.56 (′ 6.87), 18.8 (′ 5.70) and 2.45 (′ 0.88); the obtained values for reference medication were 18.29 (′ 5.39), 19.10 (′ 7.21) and 2.5 (′ 0.69). 90% CI for clarithromycin geometric mean of AUC 0 - 2 4 h , AUC 0 - i n f and C m a x ratios (test/reference) were: 93.6 - 105.9%, 93.8- 106.2% and 89 -103.2%. Conclusion: The test medication was considered bioequivalent to the reference medication based on the rate and extent of absorption. |
| Databáze: | OpenAIRE |
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