Study of Sitagliptine/ Metformin table In-Vivo Bioequivalence in healthy volunteers
Not Applicable
Recruiting
- Conditions
- In this study the bioequivalence of test and brand of Sitagliptine/ Metformin tablets 50/500mg will evaluated..
- Registration Number
- IRCT20200105046010N20
- Lead Sponsor
- Koushan Pharmed Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health (liver, heart, kidney)
Body Mass Index (BMI) between 18-28
Informed consent
Age between 18-60
Both male and female
Exclusion Criteria
Smoking
Hypersensitivity to the drug
Alcohol & Drug addiction
Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method