Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

January 28, 2023

Study Completion Date

January 28, 2023

Conditions
Muscular Atrophy, Spinal
Interventions
DRUG

risdiplam

Risdiplam will be administered orally at a single dose of 5 mg in different formulations. Dispersible tablet formulations (F21/F22) will be administered as swallowed tablet or as tablet dispersed in water. The powder for constitution to an oral solution will be administered as an oral solution constituted with purified water.

DRUG

omeprazole

Omeprazole will be administered orally as a capsule at a dose of 40 mg per day

Trial Locations (4)

32117

Daytona Beach Clinical Rsch Unit, Daytona Beach

53704

Covance Clinical Research Unit, Inc, Madison

65802

QPS- Springfield, Springfield

75247

Dallas Clinical Research Unit, Dallas

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04718181 - Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants | Biotech Hunter | Biotech Hunter