bioequivalence study of Metformin 100 mg + Sitagliptin 50 mg tablets in 24 healthy male under fasting conditions
- Conditions
- Comparative safety and efficacy of the generic Actover Co. Metformin 1000mg + Sitagliptin 50 mg tablet versus brand Janumet Merck Shop & Dohme B.V tablet in healthy male volunteers.
- Registration Number
- IRCT20180620040164N15
- Lead Sponsor
- Actover co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
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.
Subjects with known allergy to the products tested.
Subject with a history of neoplastic disease (cancer), stroke, chronic seizures or major neurological disorder, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period
History of alcohol or drug abuse within 2 years before the start of the study.
Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).