This study is performed on healthy volunteers and drug concentration in whole blood is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablet Glyxambi 25/5mg manufactured by Boehringer as a reference product. after the washout period, the volunteers receive Glypover 25/5mg tab
Sponsors
Actover Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Empagliflozin/Linagliptin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma. Timepoint: pre-dose, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 24.0, 36.0, 48.0, 72.0 and 96.0 h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration is recorded.;Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Ghasemian
Islamic Azad University
Outcome results
None listed