IRCT20180620040164N67Not yet recruitingUnknown
Comparative bioequivalence study of Metformin 1000 mg E.R. Tablet of Dorsa Pharmaceutical Co and Merck
Dorsa Pharmaceutical Co.0 sites24 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 45 years (—)
- Sex
- Male
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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