Overview

Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo

Status:
Completed

Trial end date:
2020-12-04

Target enrollment:

Participant gender:

Summary

Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Budesonide from Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) versus Uceris 9 mg Extended Release tablets (Man. for: Salix Pharm., a division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by license of Cosmo Tech. Ltd., Ireland, Product of France) in Healthy Human Volunteers Under Fasting Condition.

Phase:

Phase 1

Details

Lead Sponsor:

Genuine Research Center, Egypt

Collaborator:

Hikma Pharmaceuticals LLC

Treatments:

Budesonide