Phase 1Completed
Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)
- Sponsor
- Genuine Research Center, Egypt (Industry)
- Enrollment
- 24 enrolled
- Conditions
- Healthy
- Interventions
- Repatoxaban; Xarelto
- Ages
- adults
- Registry
- NCT03071380
Full record on ClinicalTrials.gov
From the registry
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Rivaroxaban from Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed from: Bayer Healthcare, Germany)
Primary outcomes
- Maximal measured plasma concentration (Cmax)
History
Last registry update
Registered
Study completion
Started
Primary completion