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

August 14, 2024 updated by: Dexa Medica Group

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 12430
        • PT Equilab International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
  2. 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.
  3. Aged 18 - 55 years inclusive.
  4. Preferably non-smokers or smoke less than 10 cigarettes per day.
  5. Body mass index within 18 to 25 kg/m2.

  6. 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.
  7. Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

  1. History of allergy or hypersensitivity or contraindication to tamsulosin or allied drug.
  2. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
  3. 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.
  4. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
  5. Clinically significant hematology abnormalities.
  6. Clinically significant electrocardiogram (ECG) abnormalities.
  7. 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.
  8. Past history of anaphylaxis or angioedema.
  9. History of drug or alcohol abuse within 12 months prior to screening for this study.
  10. Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
  11. History of any bleeding or coagulative disorders.
  12. Presence of difficulty in accessibility of veins in left or right arm.
  13. A donation or significant blood loss within 90 days before this study's first dosing day.
  14. 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.
  15. History of orthostatic hypotension.
  16. Scheduled for cataract or glaucoma surgery within 14 days after dosing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Tamsulosin 0.4 SR PT Dexa Medica
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)
One tablet of the test drug was given orally under fasting condition
Active Comparator: Reference Harnal OCAS 0.4 mg PR Astellas, Combiphar
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)
One tablet of the test drug was given orally under fasting condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 72 hours
Maximum plasma concentration
72 hours
AUC(0-t)
Time Frame: 72 hours
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC(0-inf)
Time Frame: 72 hours
Area under the plasma concentration-time curve extrapolated to infinitive time
72 hours
T1/2
Time Frame: 72 hours
Plasma half-life
72 hours
Tmax
Time Frame: 72 hours
Time taken to reach maximum observed plasma concentration
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dexa Medica Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BE. 827/EQL/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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