NCT06558032

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

Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film Coated Tablet Produced by PT Dexa Medica in Comparison With 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study 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 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.

Detailed description

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia)	One tablet of the test drug was given orally under fasting condition
DRUG	Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)	One tablet of the test drug was given orally under fasting condition

Timeline

• Start date: 2023-11-06
• Primary completion: 2023-12-16
• Completion: 2024-02-07
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Indonesia