| Title | Bioequivalence study of two brands of enalapril tablets after single oral administration to healthy volunteers. | | Author(s) | Niopas I, Daftsios AC, Nikolaidis N | | Institution | Department of Pharmacy, School of Health Sciences, Aristotle University of Thessaloniki, Greece. niopas@pharm.auth.gr | | Source | Int J Clin Pharmacol Ther 2003 May; 41(5):226-30. | | MeSH | Administration, Oral
Adult
Analysis of Variance
Area Under Curve
Comparative Study
Cross-Over Studies
Enalapril
Enalaprilat
Female
Half-Life
Humans
Male
Mass Fragmentography
Research Support, Non-U.S. Gov't
Tablets
Therapeutic Equivalency
Time Factors
| | Abstract | OBJECTIVE: To compare the relative bioavailability and bioequivalence of 2 enalapril tablet formulations in healthy volunteers under fasting conditions.
METHODS: An open-label, single-dose, randomized, two-period, crossover trial with a 1-week washout period in 24 healthy volunteers. The 2 enalapril 20 mg tablet formulations used were Antiprex (Elpen, Greece) as test and Renitec (Vianex, Greece) as reference preparation. Serial blood samples were collected at 19 points for 36 h. Plasma samples were analyzed for enalaprilat, the pharmacologically active metabolite of enalapril, by a validated GC/MS assay. Pharmacokinetic parameters, such as AUC(0-infinity), AUC(0-t), C(max) T(max), t1/2 and MRT were calculated from plasma concentrations for both formulations. Statistical comparisons (ANOVA and 90% confidence intervals) of AUC(0-infinity), AUC(0-t) and C(max) data were evaluated after logarithmic transformation, and differences of T(max) were tested non-parametrically.
RESULTS: The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios were 88.0 - 117.6% (point estimate: 101.8%) for AUC(0-infinity), 88.7 - 118.9% (point estimate: 102.7%) for AUC(0-t), and 91.0% - 123.4% (point estimate: 106.0%) for C(max) No statistically significant differences were found between the 2 preparations for T(max) t1/2 and MRT values.
CONCLUSIONS: From the results of the present study, it is concluded that the test and reference tablet formulations of enalapril are bioequivalent for both the extent and the rate of absorption and therefore the 2 products can be considered to be interchangeable in clinical practice. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 12776814 |
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