Bioequivalence study of empagliflozin 25 mg film-coated tablet in Thai healthy volunteers
Phase 1
- Conditions
- Healthy Thai Volunteers
- Registration Number
- TCTR20230719003
- Lead Sponsor
- Macrophar Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Healthy Thai Volunteers
Exclusion Criteria
Subjects who are with a history/evidence of drug sensitivity or allergic reaction to empagliflozin, or any related drug. Subjects who are positive for COVID-19 test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameter (Fasting condition) before (predose) and at 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours after dosing. Phoenix WinNonlin soft ware, Version 8.3 or above.
- Secondary Outcome Measures
Name Time Method AUC 0-t before (predose) and at 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours after dosing. Phoenix WinNonlin soft ware, Version 8.3 or above.