Document Detail

Relative bioavailability study of two nifedipine tablet formulations in healthy male volunteers.
MedLine Citation:
PMID:  10890580     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the bioequivalence of two oral formulations containing 10 mg of nifedipine. The test preparation were Macorel tablets, the reference preparation were Adalat tablets. SUBJECTS, MATERIAL AND METHODS: The study was designed as a single-dose, three-period crossover randomized design to 18 non-smoker, healthy male volunteers under fasting conditions. Seventeen volunteers completed the study. Plasma samples were analyzed for nifedipine by HPLC after solid-phase extraction. The pharmacokinetic parameters used to assess the bioequivalence of the two formulations were AUC(0-infinite) and AUC(0-t) for the extent of absorption and Cmax and Tmax for the rate of absorption. Statistical comparisons of AUC(0-infinite) AUC(0-t), and Cmax data were evaluated after logarithmic transformation by two-way analysis of variance (ANOVA), and differences of Tmax were tested non-parametricaly. RESULTS: Point estimates (90% confidence intervals) of the test/reference ratios were 97.4% (87.6%-108.3%) for AUC(0-infinite) 97.0% (85.6%-110.1%) for AUC0-t, and 107.7% (89.1%-130.7%) for Cmax. No statistically significant difference was found for Tmax and elimination half-life values. CONCLUSION: Therefore, in accordance with the European Union bioequivalence requirements, the test and reference nifedipine preparations are bioequivalent for both the extent and the rate of absorption.
I Niopas; A C Daftsios; I Xanthakis; N Nikolaidis
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  38     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2000 Jun 
Date Detail:
Created Date:  2000-10-19     Completed Date:  2000-10-19     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  309-14     Citation Subset:  IM    
Department of Pharmacy, School of Health Sciences, Aristotle University of Thessaloniki, Greece.
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MeSH Terms
Area Under Curve
Biological Availability
Calcium Channel Blockers / pharmacokinetics*
Cross-Over Studies
Nifedipine / administration & dosage,  pharmacokinetics*
Therapeutic Equivalency
Reg. No./Substance:
0/Calcium Channel Blockers; 0/Tablets; 21829-25-4/Nifedipine

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