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

Lucy Sasongko, Yahdiana Harahap, Budi Prasaja, Windy Lusthom, Evy C. Setiawan, Raria S. Meliala, Lipin

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7 Citations (Scopus)

Abstract

Aim: 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. 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-∞, C max andt 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-∞, C max 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. Conclusion: These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably.

Original languageEnglish
Pages (from-to)749-753
Number of pages5
JournalArzneimittel-Forschung/Drug Research
Volume60
Issue number12
Publication statusPublished - 1 Dec 2010

Keywords

  • Antihypertensives
  • Bioavailability
  • Bioequivalence
  • CAS 138402-11-6
  • CAS 58-93-5
  • Hydrochlorothiazide
  • Irbesartan

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  • Cite this

    Sasongko, L., Harahap, Y., Prasaja, B., Lusthom, W., Setiawan, E. C., Meliala, R. S., & Lipin (2010). Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects. Arzneimittel-Forschung/Drug Research, 60(12), 749-753.