Bioequivalence study of Metformin 1000 mg E.R. Tablet in 24 healthy male under fasting conditions
- Conditions
- Diabetes mellitus.Diabetes mellitus due to underlying condition
- Registration Number
- IRCT20180620040164N67
- Lead Sponsor
- Dorsa Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 18 – 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.
History of known sensitivity to the tested products
Associated acute or chronic infections
Blood pressure in standing position and after 5 minutes of rest, systole less than 90 or more than 140 mm Hg and diastole less than 50 or more than 90 mm Hg.
Heart rate less than 50 or more than 90 beats per minute
Abnormalities in ECG include (PR > 210 msec, QRS complex > 120 msec, QTcF > 430 msec)
Smoking more than 10 cigarettes a day
Loss of more than 500 ml of blood in less than 7 days.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method