Bioequivalence study of Generic Linagliptin Metformin 2/5-1000 mg versus Jentadueto (Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Receives one tablet of test drug (Linagliptin Metformin 2/5-1000 mg tablet Generic ). Blood samples were taken from the volunteers for 72 hours at the mentioned tim
Sponsors
Zist Arvand Pharmed Company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Being male Being at the age of 18 to 55 years old. Weight in range of 10 % of 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.
Exclusion criteria
Exclusion criteria: Volunteers with hypersensitivity to Linagliptin metformin Those with known history of drug abuse, alcohol consuming or cigarette smoking. Taking medications that have drug interactions with Linagliptin metformin 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, 0/75, 1, 1/5, 2, 2/5, 3, 3/5, 4, 5, 6, 8, 10, 24, 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