NCT05877222

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

A Single-center, Open-label, Randomized, Crossover Phase 1 Trial to Investigate Bioequivalence Between 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Daridorexant 10 mg	Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.
DRUG	Daridorexant 25 mg	Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.

Timeline

• Start date: 2023-06-23
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2023-05-26
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study