Bioequivalence study of Linagliptin/metformin 2.5/1000 mg tablet
Not Applicable
Recruiting
- Conditions
- This study is performed on healthy volunteers and drug concentration in whole blood is determined..
- Registration Number
- IRCT20200623047902N38
- Lead Sponsor
- Actover Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Linagliptin/metformin
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma. Timepoint: 0, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 32 h, 48 h, and 72 h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas).
- Secondary Outcome Measures
Name Time Method Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration is recorded.;Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.