Bioequivalence study of Empagliflozin Linagliptin 25-5 mg Generic versus Glyxambi (Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Receives one tablet of test drug (Empagliflozin Linagliptin 25-5 mg Generic). Blood samples were taken from the volunteers for 72 hours at the mentioned times after
Sponsors
Zist Arvand Pharmed Company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 18 to 55 years old. Weight in range of 10 % proper body weight. All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test. Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV. Just the man
Exclusion criteria
Exclusion criteria: Volunteers who were allergic to the drug components were excluded from the study. Those with known history of drug abuse. alcohol consumer or cigarette smokers. Taking medications that have drug interactions with Empagliflozin and Linagliptin until one month before studying.Disinclination to take the test. Blood donation or blood loss of more than 200 ml in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma samples. Timepoint: In times 0, 0/5, 1, 1/5, 2, 2/5, 3, 4, 5, 6, 7, 8, 9, 10, 24, 34, 48, 72 Hours after the start of the intervention. Method of measurement: Chromatography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBardia Jamali
Tam Pouya Consulting & Research Company
Outcome results
None listed