A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Tadalafil 5 mg Film-coated Tablets (CASEY 5) and Reference Product (Cialis 5 mg) in Healthy Thai Male Volunteers under Fasting and Fed Conditions
Phase 1
- Conditions
- Healthy Thai Male Volunteers
- Registration Number
- TCTR20230331004
- Lead Sponsor
- Macrophar CO., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 34
Inclusion Criteria
Healthy Thai Male Volunteers
Exclusion Criteria
1. History of allergic reaction or hypersensitivity to tadalafil 2. Have high risk for COVID-19 or diagnosed as confirmed case of COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameter (Fasting condition) 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.
- Secondary Outcome Measures
Name Time Method PK Parameter (Fed condition) 0.00 (pre-dose) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.