Healthy volunteers. ---
Conditions
Interventions
Intervention 1: Intervention group: Single dose of Rahamet (metformin 1000 mg) tablet manufactured by Raha Pharmaceuticals. Intervention 2: Intervention group: Single dose of Glucophage (metformin 100
Treatment - Drugs
Intervention group: Single dose of Rahamet (metformin 1000 mg) tablet manufactured by Raha Pharmaceuticals
Intervention group: Single dose of Glucophage (metformin 1000 mg) tablet manufactured by Merck Pharmaceuticals
Sponsors
Raha Pharmaceuticals
Gorgan University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Males, 18-50 years of age (inclusive). The subject is able and willing to provide written 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.
Exclusion criteria
Exclusion criteria: History of allergy or sensitivity to metformin hydrochloride history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or 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 psychiatric disorders occurring within the last two years that required hospitalization or medication. Presence of a medical condition requiring regular treatment with prescription drugs. 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 dosing. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: Before intervention and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC.;Area under plasma concentration-time curve. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after intervention. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax. Timepoint: During 4 hours after drug administration. Method of measurement: Blood sampling and drug analysis by HPLC. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hossein Amini
Gorgan Bioanalysis Center
Outcome results
None listed