A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers

Budi Prasaja, Yahdiana Harahap, Windy Lusthom, Evy C. Setiawan, Mena B. Ginting, Hardiyanti, Lipin

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam®) 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 design following an overnight fasting. A one-week washout period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography- tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC 0-t, AUC 0-∞, C max and t 1/2 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 AUC 0-t, AUC 0-∞, C max and t 1/2 were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.

Original languageEnglish
Pages (from-to)109-113
Number of pages5
JournalEuropean Journal of Drug Metabolism and Pharmacokinetics
Volume36
Issue number2
DOIs
Publication statusPublished - 1 Jun 2011

Keywords

  • Bioavailability
  • Bioequivalence
  • Pharmacokinetic
  • Sustained-release
  • Tamsulosin

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