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

ClinicalTrials.gov ID: NCT05877222

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT05877222
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Idorsia Pharmaceuticals Ltd.; Industry
Enrollment: 38 participants

Conditions and interventions

Conditions

Healthy

Interventions

Daridorexant 10 mg Drug
Daridorexant 25 mg Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 23, 2023 (Actual)
Primary completion: Aug 4, 2023 (Actual)
Completion: Aug 4, 2023 (Actual)
Last update posted: Aug 16, 2023

2023

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Anaheim Clinical Trials	Anaheim	California	92801	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05877222, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 16, 2023 · Synced Nov 12, 2026