title: Bioequivalence study of two clopidogrel film-coated tablet formulations in healthy volunteers.
abstract: The present study was performed to compare the bioavailability of two clopidogrel 75 mg film-coated tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 24 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were assessed based on the concentrations of clopidogrel (CAS 120202-66-6) parent compound. In each of the two study periods (separated by a washout of one week) a single dose of test or reference drug was administered. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were area under the plasma concentration-time curve from time zero to 24 h (AUCt), area under the plasma concentration-time curve from time zero to infinity (AUCinf), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (t(max)), and the elimination half life (t1/2). The geometric mean ratios (90% CI) of the test drug/reference drug for clopidogrel parent compound were 95.19% (81.63-110.90%) for AUCt, 95.55% (80.50-113.42%) for AUCinf, and 100.18% (80.87-124.09%) for Cmax. The 90% confidence intervals calculated for AUCt and Cmax of clopidogrel parent compound were within the standard bioequivalence range (80-125% for AUC and Cmax). It was concluded that the two clopidogrel film-coated tablets (test and reference drug) were bioequivalent in terms of the rate and extent of absorption.
authors.affiliation: PT Equilab International, Bioavailability and Bioequivalence Laboratory, Jakarta, Indonesia. effi@equilab-int.com
authors.forename: Effi
authors.initials: E
authors.lastname: Setiawati
authors.forename: Danang Agung
authors.initials: DA
authors.lastname: Yunaidi
authors.forename: Lucia Rat
authors.initials: LR
authors.lastname: Handayani
authors.forename: Iwan Dwi
authors.initials: ID
authors.lastname: Santoso
authors.forename: Arini
authors.initials: A
authors.lastname: Setiawati
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Tjandrawinata
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D000077144:Clopidogrel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016037:Single-Blind Method; D013608:Tablets, Enteric-Coated; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D013608:Tablets, Enteric-Coated; D000077144:Clopidogrel; D013988:Ticlopidine