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Pharmacokinetic properties and bioequivalence of two irbesartan/ hydrochlorothiazide fixed-dose combination tablets in healthy male Chinese volunteers.
- Source :
-
International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2015 Jul; Vol. 53 (7), pp. 573-81. - Publication Year :
- 2015
-
Abstract
- Objectives: The aim of the present study was to compare the pharmacokinetic profiles between a new generic and a branded reference formulation of irbesartan/ hydrochlorothiazide FDC tablets, and to assess the bioequivalence of the two products in healthy Chinese male volunteers.<br />Materials and Methods: 24 male healthy volunteers participated in the open-label, single-dose, randomized-sequence, 2-way crossover study. Eligible subjects were randomly assigned (1:1) to receive a single 300/12.5-mg dose of either the test or reference formulation followed by a 1-week washout. Blood samples were obtained before (0 hours) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours after dosing. Plasma concentrations of irbesartan and hydrochlorothiazide were analyzed by two separate validated liquid chromatography/tandem mass spectrometric (LC-MS/MS) methods.<br />Results: For irbesartan, the 90% confidence intervals (CIs) of AUC0-t, AUC0-∞, and Cmax were 103.27-116.71%, 105.01-121.47%, and 84.15-96.88%, respectively. For hydrochlorothiazide, the 90% CIs of AUC0-t, AUC0-∞, and Cmax were 96.11-109.02%, 95.15-107.35%, and 91.66-101.40%, respectively. A total of 3 mild AEs were reported in 3 subjects (12.5%).<br />Conclusion: In this study, a single dose (300/12.5-mg) of the test formulation of irbesartan and hydrochlorothiazide FDC tablet in fasting healthy Chinese male volunteers met WHO's and China's FDA regulatory criteria for assumption of bioequivalence to the reference formulation based on AUC and Cmax. Both formulations were well tolerated.
- Subjects :
- Administration, Oral
Adult
Angiotensin II Type 1 Receptor Blockers administration & dosage
Angiotensin II Type 1 Receptor Blockers adverse effects
Angiotensin II Type 1 Receptor Blockers blood
Antihypertensive Agents administration & dosage
Antihypertensive Agents adverse effects
Antihypertensive Agents blood
Area Under Curve
Asian People
Biphenyl Compounds administration & dosage
Biphenyl Compounds adverse effects
Biphenyl Compounds blood
China
Chromatography, High Pressure Liquid
Cross-Over Studies
Diuretics administration & dosage
Diuretics adverse effects
Diuretics blood
Drug Combinations
Drugs, Generic administration & dosage
Drugs, Generic adverse effects
Healthy Volunteers
Humans
Hydrochlorothiazide administration & dosage
Hydrochlorothiazide adverse effects
Hydrochlorothiazide blood
Irbesartan
Male
Metabolic Clearance Rate
Tablets
Tandem Mass Spectrometry
Tetrazoles administration & dosage
Tetrazoles adverse effects
Tetrazoles blood
Therapeutic Equivalency
Young Adult
Angiotensin II Type 1 Receptor Blockers pharmacokinetics
Antihypertensive Agents pharmacokinetics
Biphenyl Compounds pharmacokinetics
Diuretics pharmacokinetics
Drugs, Generic pharmacokinetics
Hydrochlorothiazide pharmacokinetics
Tetrazoles pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0946-1965
- Volume :
- 53
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- International journal of clinical pharmacology and therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 25828636
- Full Text :
- https://doi.org/10.5414/CP202208