Bioequivalence study of Metformin ER 500 mg tablet (Saponine Iran) versus Glucophage® XR 500 mg (Merck-Brand) Tablet in healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Receives one tablet of test drug (Metformin ER 500 mg tablet Saponine Iran Pharmaceutical Company). Blood samples were taken from the volunteers for 24 hours at the
Sponsors
Saponine Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 18 to 50 years old Weight in range of 10 % proper body weight All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test. and possessing negative test for hepatitis B surface antigen (HBs-Ag), antihepatitis-C antibody (anti-HCV), and anti-HIV. just man
Exclusion criteria
Exclusion criteria: Volunteers with hypersensitivity to Metformin were excluded. those with known history of drug abuse. alcohol consumer or cigarette smokers. Taking medications that have drug interactions with Metformin until one month before studying. disinclination to take the test Blood donation or blood loss of more than 200 ml in the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma samples. Timepoint: In times 0, 0/25, 0/5, 0/75, 1, 1/25, 1/5, 1/75, 2, 2/5, 3, 4, 6, 8, 10, 24, 30 Hours after the start of the intervention. Method of measurement: chromatography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBardia Jamali
Tam Pouya Consulting & Research Company
Outcome results
None listed