title: Bioequivalence study of generic amlodipine in healthy Thai male volunteers.
abstract: METHODS
  To determine the bioequivalence of 10 mg generic amlodipine in healthy male volunteers, the reference and the test formulations were administered as a single oral dose after overnight fasting in a crossover study separated by 2-week washout interval. After dosing, serial blood samples were collected for a period of 144 h. Plasma amlodipine concentrations were determined by LC-MS/MS and the pharmacokinetic parameters were analyzed by non-compartmental analysis.
  
  
  RESULTS
  The mean elimination half-life (t1/2) for the test (40 h) and the reference (44 h) were within the values previously reported. The rate of absorption reflected by tmax had a difference of -0.33 h, with a 90% CI of (-1.52)-0.85 (acceptable range +/- 1.3). Although the tmax of the test (5 h) was faster than the reference (6 h), the mean (90% CI) of the AUC(0-infinity) and Cmax ratios Test/Reference were 0.91 (0.87-0.97) and 1.01 (0.93-1.09), respectively. These values were within the range of 0.80-1.25, thus, the study demonstrated the bioequivalence of the 2 formulations.
authors.affiliation: Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. nrojanas@med.cmu.ac.th
authors.forename: N
authors.initials: N
authors.lastname: Rojanasthien
authors.forename: S
authors.initials: S
authors.lastname: Teekachunhatean
authors.forename: K
authors.initials: K
authors.lastname: Jakob
authors.forename: M
authors.initials: M
authors.lastname: Gaupp
authors.forename: P
authors.initials: P
authors.lastname: Arnold
authors.forename: N
authors.initials: N
authors.lastname: Chaichana
authors.forename: W
authors.initials: W
authors.lastname: Martin
mesh_terms: D000328:Adult; D017311:Amlodipine / Q000097:blood / Q000493:pharmacokinetics*; D000704:Analysis of Variance; D019540:Area Under Curve; D002121:Calcium Channel Blockers / Q000097:blood / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D013785:Thailand; D013810:Therapeutic Equivalency
chemical_list: D002121:Calcium Channel Blockers; D017311:Amlodipine