Phase 1Completed
Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)
Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets (Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)
- Sponsor
- Genuine Research Center, Egypt (Industry)
- Enrollment
- 24 enrolled
- Conditions
- Healthy
- Interventions
- Prevaglip (linagliptin); Trajenta (linagliptin)
- Ages
- adults
- Registry
- NCT02857946
Full record on ClinicalTrials.gov
From the registry
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals \& Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International GmbH, Germany) after a single oral dose administration of each to healthy adults under fasting conditions
Primary outcomes
- Maximal measured plasma concentration (Cmax)
History
Registered
Study completion
Primary completion
Started