Bioequivalence study of tadalafil 5 mg film-coated tablet in Thai healthy volunteers

Phase 4

• Conditions: Thai healthy male subjects , Aged 18 †50 years , BMI were within 18- 25 kg/m2 , Good health confirming by physical and clinical

• Registration Number: TCTR20190806005
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Study Completion: 2019-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Subjects who are Thai male, aged 18 to 50 years (inclusive).
2. Subjects whose BMI is 18.0-25.0 kg/m2 (inclusive).
3. Subjects who are healthy by medical history, physical examination, vital signs and EKG.
4. Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. HBsAg is negative.
5. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
6. Alcohol breath test is negative.

Exclusion Criteria

1. Subjects who are with a history/evidence of drug sensitivity or allergic reaction to tadalafil, or any related drug.
2. Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects.
3. Subjects who have significant of abnormal EKG (depend on clinical investigator decision).
4. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least three days before the study and until the completion of the study period.
5. Subjects who are with a history of alcoholic (more than 2 years) or for men, more than 4 drinks on any single day and more than 14 drinks per week.
6. Subjects who are with a history of any drug abuse. eg. Morphine, methamphetamine, tetrahydrocannabinol (marijuana).
7. Subjects who receive of any medical prescription, herbal medicine and food supplement within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzyme.
8. Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioequivalence 12 months 90% confidence interval of Cmax, AUC0-t and AUC0-inf

Secondary Outcome Measures

Name	Time	Method
Drug concentration in plasma-time profile and pharmacokinetic parameters 12 months Cmax,Tmax, AUC, Half-life (data from the individual concentration vs time)