Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects.
OBJECTIVE
The bioavailability of two 300 mg irbesartan (CAS 138402-11-6)/12.5 mg hydrochlorothiazide (CAS 58-93-5) tablet formulations was compared, using Co-Ir-vell tablets as test formulation and the originator product as reference formulation.


METHODS
Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover study following an overnight fasting. A two-week wash-out period was applied. Blood samples were drawn up to 48 h following drug administrations. Irbesartan and hydrochlorothiazide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax and t were determined and used for bioequivalence evaluation after log-transformation, whereas t max ratios were evaluated non-parametrically.


RESULTS
The estimated point and 90% confidence intervals (CI) for AUC(0-t), AUC(0-infinity), Cmax and t for irbesartan were 97.74% (85.40-111.86%), 96.36% (83.25-111.55%), 103.30% (90.65-117.71%), 92.38% (82.68-103.21%) and for hydrochlorothiazide, 106.30% (97.72-115.63%), 106.28% (98.14-115.10%), 108.01% (95.48-122.18%), 105.52% (96.70-115.14%), respectively.


CONCLUSIONS
These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably.
School of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia.
Lucy
L
Sasongko
Yahdiana
Y
Harahap
Budi
B
Prasaja
Windy
W
Lusthom
Evy C
EC
Setiawan
Raria S
RS
Meliala
Lipin
D000293:Adolescent; D000328:Adult; D047228:Angiotensin II Type 1 Receptor Blockers / Q000493:pharmacokinetics*; D000959:Antihypertensive Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D001713:Biphenyl Compounds / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004232:Diuretics / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000493:pharmacokinetics*; D007214:Indonesia; D000077405:Irbesartan; D008297:Male; D013058:Mass Spectrometry; D013777:Tetrazoles / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D055815:Young Adult
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004232:Diuretics; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D000077405:Irbesartan