Diabetes mellitus due to underlying condition. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group 1: Dapagliflozin/ Metformin 5/ 1000 mg Tablet, produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this
Sponsors
Actover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age. 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 abnormal findings during laboratory evaluations and clinical examination.Subjects with normal vital signs. Candidates must have normal vital signs. The consent of the candidates to all the requirements of the clinical study based on the instructions of the clinical study, which has been confirmed by accepting the informed consent form.
Exclusion criteria
Exclusion criteria: Sensitivity to the pharmaceutical substance being studied. Cardiovascular, pulmonary, acute or chronic hormonal nervous system disease, gastrointestinal disease, and visual impairments on ophthalmology examinations. A history of mental illness, water loss due to diarrhea or vomiting that lasts 24 hours before the medication is given. Systolic blood pressure greater than 130 or less than 100 mmHg. Diastolic blood pressure greater than 85 or less than 60 mmHg. Smokers who smoke more than 10 cigarettes a day and have problems with not smoking during each clinical study period. People who have used over the counter or doctor-prescribed medications 14 days before the start of the first period will need to take the medication at the same time during the study. People who have a history of alcoholism or alcohol consumption within the past 2 years. Volunteers who are heavy drinkers of caffeinated beverages, fruit juices (grapefruit juice) or follow a special diet (vegetarianism) or do heavy physical activity. A history of difficulty donating blood or donating more than 500 mL of blood less than seven days before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 11, 24 and 48 hours after intervention.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: 14 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 11, 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