Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg
Not Applicable
Recruiting
- Conditions
- Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg (Tehran Chemie Pharmaceutical Company) versus Synjiardy(Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers.
- Registration Number
- IRCT20220111053692N17
- Lead Sponsor
- Tehran Chemie Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Being male
Being at the age of 18 to 55 years old.
Weight in range of 10 % of proper body weight.
All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test.
Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Exclusion Criteria
Volunteers with hypersensitivity to Empagliflozin metformin
Those with known history of drug abuse, alcohol consuming or cigarette smoking.
Taking medications that have drug interactions with Empagliflozin metformin until one month before studying.
Disinclination to take the test.
Blood donation or blood loss of more than 200 ml in the past month.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma samples. Timepoint: In times 0, 0/5, 0/75, 1, 1/5, 2, 2/5, 3, 3/5, 4, 4/5, 5, 6, 8, 10, 24, 48 Hours after the start of the intervention. Method of measurement: Chromatography.
- Secondary Outcome Measures
Name Time Method