title: A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.
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 wash-out 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 (½) were determined and used for bioequivalence evaluation after log-transformation, whereas t (max) ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC(0-t,) AUC(0-∞), C (max) and t (½) 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.
authors: Clinisindo Laboratories, Jakarta, Indonesia. budi.prasaja@clinisindo.com
authors: Budi
authors: B
authors: Prasaja
authors: Yahdiana
authors: Y
authors: Harahap
authors: Windy
authors: W
authors: Lusthom
authors: Evy C
authors: EC
authors: Setiawan
authors: Mena B
authors: MB
authors: Ginting
authors: Hardiyanti
authors: Lipin
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006207:Half-Life; D006801:Humans; D007214:Indonesia; D008297:Male; D013058:Mass Spectrometry; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D013607:Tablets; D000077409:Tamsulosin; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D013449:Sulfonamides; D013607:Tablets; D000077409:Tamsulosin