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 Tech. Ltd., Ireland, Product of France)

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 17, 2020

Primary Completion Date

October 1, 2020

Study Completion Date

December 4, 2020

Conditions
Healthy
Interventions
DRUG

Ekmasonid

1 extended release tablet contains 9 mg Budesonide

DRUG

Uceris (first dose)

1 extended release tablet contains 9 mg Budesonide

DRUG

Uceris (second dose)

1 extended release tablet contains 9 mg Budesonide

Trial Locations (1)

11757

Genuine Research Center GRC, Cairo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hikma Pharmaceuticals LLC

INDUSTRY

lead

Genuine Research Center, Egypt

INDUSTRY

NCT04854538 - 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 Tech. Ltd., Ireland, Product of France) | Biotech Hunter | Biotech Hunter