igagliptin tablets 5mg ABIDI Pharmaceuticals (TRAJENTA® 5mg Tab) , In- Vivo Bioequivalence in Iranian healthy volunteers.
Not Applicable
- Conditions
- In this study the bioquivalence of test and brand of Ligagliptin tablets 5mg will evaluated..
- Registration Number
- IRCT20200105046010N8
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health(liver, heart, kidney)
Body mass index(18-28)
Informed consent
Age(18-60)
Exclusion Criteria
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC,LC-MS/MS or UPLC-MS/MS.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters. Timepoint: Immediately after the intervention. Method of measurement: Theoretically and using pharmacokinetic equations.