Bioequivalence study of sitagliptin-metformin 50/500 mg tablets under fasting conditions
- Conditions
- ..
- Registration Number
- IRCT20130626013776N14
- Lead Sponsor
- Aramis Pharmed Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Males, 18-50 years of age.
The subject is able and willing to provide signed informed consent.
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has stable residence and telephone.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
History of allergy or sensitivity to metformin or sitagliptin.
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of a medical disorders occurring within the last year that required hospitalization or medication.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to the present study.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 and 48 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC.;Area under plasma concentration-time curve. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 and 48 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC.
- Secondary Outcome Measures
Name Time Method Time to reach Cmax. Timepoint: During 6 hours after drug administration. Method of measurement: Blood sampling and drug analysis by HPLC.;Plasma half-life. Timepoint: From the terminal 16 hours of plasma concentration-time profile. Method of measurement: Blood sampling and drug analysis by HPLC.