Arzneimittelforschung 2010; 60(12): 749-753
DOI: 10.1055/s-0031-1296350
Editio Cantor Verlag Aulendorf (Germany)

Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects

Lucy Sasongko
1   School of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia
Yahdiana Harahap
2   Department of Pharmacy, Faculty of Mathematics and Science, University of Indonesia, Depok, Indonesia
Budi Prasaja
3   Clinisindo Laboratories, Jakarta, Indonesia
Windy Lusthom
3   Clinisindo Laboratories, Jakarta, Indonesia
Evy C Setiawan
3   Clinisindo Laboratories, Jakarta, Indonesia
Raria S Meliala
3   Clinisindo Laboratories, Jakarta, Indonesia
L Lipin
3   Clinisindo Laboratories, Jakarta, Indonesia
› Author Affiliations
Further Information

Publication History

Publication Date:
03 December 2011 (online)



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-Irvell® tablets as test formulation and the originator product as reference formulation.


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 AUC0–t, AUC0–∞, Cmax and t were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated non-parametrically.


The estimated point and 90% confidence intervals (CI) for AUC0–t, AUC0–∞, 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.


These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably.

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