Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

July 25, 2022

Study Completion Date

October 25, 2022

Conditions
Healthy
Interventions
DRUG

Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose)

1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

DRUG

Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test)

1 tablet Mirfenacin MR contains Solifenacine succinate 5 mg \& Mirabegron 50 mg orally administrated followed by 240 ml of water

DRUG

Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)

1 tablet Vesicare contains Solifenacine succinate 5 mg \& 1 tablet Betmiga contains Mirabegron 50 mg orally administrated followed by 240 ml of water

Trial Locations (1)

11757

Genuine Research Center GRC, Cairo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hikma Pharma

UNKNOWN

lead

Genuine Research Center, Egypt

INDUSTRY