None listed
Conditions
Interventions
Intervention group: This study examines the bioequivalence of dapagliflozin produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control grou
Sponsors
KIMIA Noavaran Daroui
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The weight range of participating candidates must be between 60-100 kg. All candidates must be non-smokers. The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose. Volunteers who agreed to the informed consent form.
Exclusion criteria
Exclusion criteria: History of allergic or adverse reaction to dapagliflozin or any similar product. Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg. Smokers. People who 10 days before the first day of consumption, Drug-experienced Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 15 sampling time till 48 h. Method of measurement: LCMSMS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed