I. Niopas et al., Relative bioavailability study of two nifedipine tablet formulations in healthy male volunteers, INT J CL PH, 38(6), 2000, pp. 309-314
Citations number
20
Categorie Soggetti
Pharmacology & Toxicology
Journal title
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Objective: To assess the bioequivalence of two oral formulations containing
10 mg of nifedipine. The test preparation were Macorel tablets, the refere
nce preparation were Adalat tablets. Subjects, material and methods: The st
udy was designed as a single-dose, three-period crossover randomized design
to 18 non-smoker, healthy male volunteers under fasting conditions. Sevent
een volunteers completed the study. Plasma samples were analyzed for nifedi
pine by HPLC after solid-phase extraction. The pharmacokinetic parameters u
sed to assess the bioequivalence of the two formulations were AUC(0-infinit
y), and AUC(0-t) for the extent of absorption and C-max and T-max for the r
ate of absorption. Statistical comparisons of AUC(0-infinity),, AUC(0-t) an
d C-max data were evaluated after logarithmic transformation by two-way ana
lysis of variance (ANOVA),and differences of T-max were tested non-parametr
icaly. Results: Point estimates (90% confidence intervals) of the test/refe
rence ratios were 97.4% (87.6% - 108.3%) for AUC(0-infinity) 97.0% (85.6% -
110.1%) for AUC(0-t), and 107.7% (89.1% - 130.7%) for C-max. No statistica
lly significant difference was found for T-max and elimination half-life va
lues. Conclusion: Therefore, in accordance with the European Union bioequiv
alence requirements, the test and reference nifedipine preparations are bio
equivalent for both the extent and the rate of absorption.