Format

Send to

Choose Destination
Int J Clin Pharmacol Ther. 2009 Mar;47(3):187-94.

Single-dose randomized, open-label, 2-way crossover bioequivalence study of clopidogrel 75 mg tablet in healthy volunteers under fasting conditions.

Author information

1
Medical Department, Grupo Tecnimede, Abrunheira, Sintra, Portugal. dmed.ct@tecnimede.pt

Abstract

AIM:

This study aimed to assess the bioequivalence of 2 formulations of 75 mg clopidogrel hydrogen sulphate film-coated tablet, under fasting conditions.

SUBJECTS AND METHODS:

64 healthy subjects, age ranging from 19 to 55 years, were enrolled in a single-centre, randomized, single-dose, open-label, 2-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected up to 24 h post dosing. Clopidogrel and clopidogrel carboxylic acid levels were determined by reverse-phase high-performance chromatography coupled to tandem mass spectrometry detection, LC-MS-MS method. Pharmacokinetic parameters used for bioequivalence assessment were the AUClast (area under the concentration-time curve from time zero to time of last observed nonzero concentration) and the Cmax (maximum observed concentration). These parameters were determined from the clopidogrel concentration data using non-compartmental analysis as well for clopidogrel carboxylic acid concentration data.

RESULTS:

The 90% CI (90% confidence intervals), obtained by analysis of variance (ANOVA) were within the predefined ranges (80.00 - 125.00%) for both analytes.

CONCLUSION:

Bioequivalence between test and formulations, under fasting conditions, was concluded both in terms of rate and extent of absorption.

PMID:
19281728
[Indexed for MEDLINE]

Supplemental Content

Loading ...
Support Center