IRCT20180620040164N52
Completed
未知
Bioequivalence study of empagliflozin 12.5 combined tablet with metformin 1000 mg of Daro Darman Pars company in comparison with the reference sample of Syngardi made by Boehringer company.
Darou darman Pars Co.0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Darou darman Pars Co.
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18\.5 and 30 (inclusive), calculated as kg/m2\.
- •Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
- •Subjects with normal vital signs.
- •Subjects who agree with patient consent form.
Exclusion Criteria
- •Subjects with known allergy to the products tested.
- •History of diabetes or other endocrine diseases
- •moking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
- •A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Outcomes
Primary Outcomes
Not specified
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