Bioequivalence study of empagliflozin 10 mg tablet
Not Applicable
Recruiting
- Conditions
- In the present study, no disease was investigated..
- Registration Number
- IRCT20230222057495N3
- Lead Sponsor
- Yab Daro Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Be between 18 and 50 years old.
All candidates must be non-smokers.
The Volunteer's body mass index (BMI) should be less than 30 kg for the square of their height in meters.
Exclusion Criteria
Volunteers with blood pressure less than 90/60 mm Hg or higher than 140/90 mm Hg.
Volunteers should refrain from smoking, consuming alcohol, caffeine (including coffee, cocoa, tea, cola drinks) 48 hours before the start of the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Empagliflozin plasma concentrations. Timepoint: 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours. Method of measurement: HPLC-MS/MS.
- Secondary Outcome Measures
Name Time Method