title: Average bioequivalence study of clarithromycin tablets in healthy male volunteers.
abstract: OBJECTIVE
  To evaluate the average bioequivalence of two formulations of 500 mg clarithromycin tablets in 24 healthy Thai male volunteers.
  
  
  METHODS
  In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500 mg clarithromycin tablet. Plasma samples were collected over a 24-h period after administration and were analysed by using a validated HPLC-ECD method. Pharmacokinetic parameters were determined by using non-compartmental analysis.
  
  
  RESULTS
  The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL) and the area under the curve (AUC0- infinity, ng h/mL) of the Reference and Test formulations were 2.0 +/- 0.9 vs. 1.8 +/- 1.1, 3018 +/- 841 vs. 3014 +/- 752 and 23142 +/- 7348 vs. 22810 +/- 6027, respectively. The 90% confidence interval of Cmax and AUC0- infinity were 90.6-109.4 and 89.6-110.1%.
  
  
  CONCLUSIONS
  Bioequivalence between the Test and Reference formulation can be concluded.
authors.affiliation: Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. manupatl@hotmail.com
authors.forename: M
authors.initials: M
authors.lastname: Lohitnavy
authors.forename: O
authors.initials: O
authors.lastname: Lohitnavy
authors.forename: K
authors.initials: K
authors.lastname: Sareekan
authors.forename: W
authors.initials: W
authors.lastname: Chaiyaput
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D017291:Clarithromycin / Q000097:blood / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D017291:Clarithromycin