This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablet GLYXAMBI® 25/5 mg manufactured by Boehringer as a reference product. after washout period, the volunteers receive Empagliflozin/Linagl
Sponsors
Kharazmi Pharmaceutical 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 Alcohol and drug addiction History of allergy to Empagliflozin or linagliptin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0? 0.5? 1? 1.5? 2? 2.5? 0?3? 3.5? 4.0? 6.0? 8.0? 10? 12? 24? 48 , 72h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed