Comparative Bioavailability of two immediate release tablets of enalapril/hydrochlorothiazide in healthy volunteers
| Autor: | Maria Cruz Caturla, Nuno E. Silva, José A. Morais, Augusto E. P. Filipe, M. Rovira, Manuela T. Maya, Nuno J. Goncalves |
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| Přispěvatelé: | Repositório da Universidade de Lisboa |
| Jazyk: | angličtina |
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male Enalaprilat Chemistry Pharmaceutical Cmax Administration Oral Biological Availability Pharmacology Bioequivalence Statistics Nonparametric Dosage form Hydrochlorothiazide Enalapril Pharmacokinetics Confidence Intervals medicine Humans Pharmacology (medical) Pharmacology & Pharmacy Analysis of Variance Cross-Over Studies Chromatography Chemistry Bioavailability Area Under Curve Tablets medicine.drug |
| Zdroj: | Scopus-Elsevier Repositório Científico de Acesso Aberto de Portugal Repositório Científico de Acesso Aberto de Portugal (RCAAP) instacron:RCAAP |
| Popis: | A bioequivalence study of two oral formulations of 20/12.5 mg tablets of enalaptil/hydrochlorothiazide was carried out in 20 healthy male volunteers according to a single dose, two-sequence, crossover randomized design. One washout period of nine days was observed between the two periods. Multiple samples were collected over 96 hours post-dosing. Bioavailability was evaluated on the basis of plasma concentrations of enalapril and its main active metabolite, enalaprilat and hydrochlorothiazide. Plasma samples were assayed for enalapril, enalaprilat and hydrochlorothiazide using a selective and sensitive high-performance liquid chromatography method with mass spectrometry detection (LC-MS). The pharmacokinetic parameter values of C-max and t(max) were obtained directly from plasma data, k(e) was estimated by log-linear regression, and AUC was calculated by trapezoidal rule. Different statistical tests were performed on the basis of untransformed and log-transformed data and the overall residual variance from ANOVA. Assuming the accepted tolerance intervals, a beta-error of 20% and 90% confidence intervals (alpha = 0.10), all the generally accepted tests (Schuirmann test and Wilcoxon-Tukey and Hauschke nonparametric tests) showed that the formulations can be considered as bioequivalent with respect to the extent of absorption, given by the AUC(0-infinity) and with respect to rate of absorption as assessed by C-max and t(max). |
| Databáze: | OpenAIRE |
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