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Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects
Lucy Sasongko1, Yahdiana Harahap, Budi Prasaja
1School of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia.
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-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.
Conclusion:
These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably.
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