NCT06920719

Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers

Detailed description

62 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	YHP2406	Test drug: YHP2406, Comparator: YHR2501
DRUG	YHR2501	Test drug: YHP2406, Comparator: YHR2501

Timeline

• Start date: 2025-06-29
• Primary completion: 2025-07-01
• Completion: 2025-07-09
• First posted: 2025-04-10
• Last updated: 2025-07-24

Locations

1 site across 1 country: South Korea