Diabetes mellitus. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group1(test): Metformin 1000 mg E.R. Tablet, produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of
Sponsors
Dorsa Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 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.
Exclusion criteria
Exclusion criteria: History of known sensitivity to the tested products Associated acute or chronic infections Blood pressure in standing position and after 5 minutes of rest, systole less than 90 or more than 140 mm Hg and diastole less than 50 or more than 90 mm Hg. Heart rate less than 50 or more than 90 beats per minute Abnormalities in ECG include (PR > 210 msec, QRS complex > 120 msec, QTcF > 430 msec) Smoking more than 10 cigarettes a day Loss of more than 500 ml of blood in less than 7 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 15 blood samples will be withdrawn pre-dose and at 1, 1.5, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 15 blood samples will be withdrawn pre-dose and at 1, 1.5, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehzad Montaha Sangari
Noor Research & Development Institute
Outcome results
None listed