Health and normal volunteers. --
Conditions
Interventions
Intervention 1: Intervention group: Single dose of Metformin 750 mg tablet manufactured by Koushan Pharmed Pharmaceutical company in 24 healthy volunteers. Intervention 2: Intervention group: Single d
Sponsors
Kushan Pharmed Company
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 24 healthy male and female volunteers will participate in this study. Aged 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study, adherence to the criteria on the basis of moral obligation and signed an informed consent; actual weight (TBW) in the range of 20% IBW Exclusion criteria: Age outside the range mentioned; acute or chronic smoking or alcohol, failure to obtain any of the above health tests, medication two weeks before the experiment
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h following drug administration. Method of measurement: Using HPLC instrument. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0; 12.0; 16.0; 20.0; 24.0; 30.0 and 36 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Katayoun Derakhshandeh
Hamedan University of Medical Sciences
Outcome results
None listed