NCT06623526

Clinical Trial to Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers

An Open-label, Randomized, Fasting, Single-Crossover Study to Compare the Pharmacokinetic Interactions and Safety of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects

Detailed description

26 healthy subjects will be randomized to one of the 2 groups in the same ratio. "YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15 "YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	YHR2402	Test Drug: YHR2402
DRUG	YHR2402+YHR2403	Test Drug: YHR2402+YHR2403

Timeline

• Start date: 2024-10-04
• Primary completion: 2024-11-06
• Completion: 2024-11-11
• First posted: 2024-10-02
• Last updated: 2024-11-22

Locations

1 site across 1 country: South Korea