A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablets (LEZIGA) and Reference Product (Trajenta) in Healthy Thai Volunteers under Fasting Conditions
Phase 1
- Conditions
- Healthy Thai Volunteers
- Registration Number
- TCTR20221031003
- Lead Sponsor
- MacroPhar Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Unknown
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Healthy Thai Volunteers
Exclusion Criteria
1 History of alleric reaction or hypersensitivity to linagliptin
2 History or evidence of clinically significant renal, hepatic, GI, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, allergic disease or any significant ongoing chronic medical illness.
3 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 parameters 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 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 Cmax 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 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