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A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
Phase 1
Waitlist Available
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if two different doses of a drug are equally effective in healthy Japanese men & women.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment B (5 × 25 mg daridorexant)Experimental Treatment1 Intervention
Participants will receive a single oral dose of 2 × 25 mg daridorexant.
Group II: Treatment A (5 × 10 mg daridorexant)Experimental Treatment1 Intervention
Participants will receive a single oral dose of 5 × 10 mg daridorexant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daridorexant 25 mg
2023
Completed Phase 3
~1810
Daridorexant 10 mg
2023
Completed Phase 3
~850
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,925 Total Patients Enrolled
Clinical Trials Study DirectorStudy DirectorIdosia Pharmaceuticals Ltd
3 Previous Clinical Trials
2,904 Total Patients Enrolled