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

NCT06558032 | Completed Phase 1

• 1 other identifier: BE. 827/EQL/2023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC(0-t)

  Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t

  72 hours

• Cmax

  Maximum plasma concentration

  72 hours

Secondary Outcomes (3)

• AUC(0-inf)

  72 hours

• T1/2

  72 hours

• Tmax

  72 hours

Study Arms (2)

Test Tamsulosin 0.4 SR PT Dexa Medica

EXPERIMENTAL

Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia)

Drug: Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia)

Reference Harnal OCAS 0.4 mg PR Astellas, Combiphar

ACTIVE COMPARATOR

Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)

Drug: Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)

Interventions

Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia) DRUG

One tablet of the test drug was given orally under fasting condition

Test Tamsulosin 0.4 SR PT Dexa Medica

Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) DRUG

One tablet of the test drug was given orally under fasting condition

Reference Harnal OCAS 0.4 mg PR Astellas, Combiphar

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
• Healthy male subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
• Aged 18 - 55 years inclusive.
• Preferably non-smokers or smoke less than 10 cigarettes per day.
• Body mass index within 18 to 25 kg/m2.
• Vital signs (after 10 minutes rest) must be within the following ranges:
• Systolic blood pressure: 110 - 129 mmHg
• Diastolic blood pressure: 70 - 84 mmHg
• Pulse rate: 60 - 90 bpm.
• Willing to practice abstention or non-hormonal contraception during the study.

You may not qualify if:

• History of allergy or hypersensitivity or contraindication to tamsulosin or allied drug.
• Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
• Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Clinically significant hematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening for this study.
• Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
• History of any bleeding or coagulative disorders.
• Presence of difficulty in accessibility of veins in left or right arm.
• A donation or significant blood loss within 90 days before this study's first dosing day.
• Intake of any prescription (especially tamsulosin), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study's first dosing day.
• History of orthostatic hypotension.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

PT Equilab International

Jakarta, 12430, Indonesia

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a bioequivalence study

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: November 6, 2023
• Primary Completion: December 16, 2023
• Study Completion: February 7, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

ID (1)