Phase 1Completed
A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
- Sponsor
- Genuine Research Center, Egypt (Industry)
- Enrollment
- 36 enrolled
- Conditions
- Healthy
- Interventions
- Amlodipine/Valsartan; Exforge
- Ages
- adults
- Registry
- NCT02519010
Full record on ClinicalTrials.gov
From the registry
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).
Primary outcomes
- Bioequivalence based on Cmax
- Bioequivalence based on AUC parameters
History
Registered
Started
Primary completion