Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated Tablets

The objective of this study was to find out whether the bioavailability of tamsulosin 0.4 mg sustained release film coated tablet produced by PT Dexa Medica is equivalent to that of the comparator drug (Harnal® OCAS 0.4 mg Prolonged Release Tablet produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) when administered under fasting condition in healthy subjects. This was an open-label, randomized, single-dose, four-period, two-sequence, fully replicate study under fasting conditions which included 28 healthy adult male subjects. The participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally the test drug (tamsulosin 0.4 mg sustained release film coated tablet produced by PT Dexa Medica) or the comparator drug (Harnal® OCAS 0.4 mg Prolonged Release Tablet produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) with total 200 mL of water. The subjects' oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of Tamsulosin following single dose administration. The plasma concentrations of Tamsulosin were determined by using validated ultra-performance liquid chromatography with tandem mass spectroscopy detection (UPLC-MS/MS method).