title: Pharmacokinetics and bioequivalence study of irbesartan tablets after a single oral dose of 300 mg in healthy Thai volunteers.
abstract: OBJECTIVE
  Pharmacokinetics and bioequivalence of 300 mg irbesartan tablets were studied in 26 healthy Thai male volunteers.
  
  
  METHODS
  A single oral dose of one 300 mg tablet of the test product and the reference product was given to each volunteer according to a randomized two-way crossover design with 1-week wash out period. Blood samples were collected at predetermined time intervals until 72 hours post dose and irbesartan concentration was quantified with a validated HPLC method. Individual plasma irbesartan concentration-time profile was analyzed for pharmacokinetic parameters.
  
  
  RESULTS
  Maximum plasma concentrations (Cmax) of 3,617.19 and 3,295.77 ng/mL for test and reference, respectively, were achieved. Areas under the plasma concentration-time curve; AUC0-t and AUC0-∞ were 15,304.65 and 15,638.90 ng×h/mL for test and 15,389.21 and 15,730.34 ng×h/mL for reference. The median tmax was 1.50 hours and 1.25 hours for test and reference, respectively. Plasma elimination half-lives (t1/2) were 7.35 hours and 8.09 hours for test and reference, respectively. Primary pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ were tested parametrically by analysis of variance (ANOVA), and it revealed no statistically significant difference (defined as p < 0.05) between the corresponding Cmax, AUC0-t, and AUC0-∞ with respect to sequence, volunteers, period and formulation. The 90% confidence intervals for the ratio of test and reference product of the parameters Cmax, AUC0-t, and AUC0-∞ were within 80 - 125% (100.13 - 121.40% for Cmax, 90.83 - 106.86% for AUC0-t and 91.11 - 106.55% for AUC0-∞).
  
  
  CONCLUSIONS
  The two products were bioequivalent in terms of both rate and extent of drug absorption into systemic circulation.
authors.forename: Supeecha
authors.initials: S
authors.lastname: Wittayalertpanya
authors.forename: Pajaree
authors.initials: P
authors.lastname: Chariyavilaskul
authors.forename: Nantaporn
authors.initials: N
authors.lastname: Prompila
authors.forename: Nonlanee
authors.initials: N
authors.lastname: Sayankuldilok
authors.forename: Wanna
authors.initials: W
authors.lastname: Eiamart
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D000077405:Irbesartan; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013785:Thailand; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D013607:Tablets; D013777:Tetrazoles; D000077405:Irbesartan