NCT06775522

Bioequivalence (BE) Study Between YHP2205 and YHR2401 in Healthy Volunteers

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 YHP2205 and YHR2401 in healthy volunteers

Detailed description

60 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "YHP2205" and "comparator" by crossover design on day 1, 8 Subjects in group 2 will be administered "comparator" and "YHP2205" by crossover design on day 1, 8.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	YHP2205	Test drug: YHP2205 Comparator: YHR2401
DRUG	YHR2401	Test drug: YHP2205 Comparator: YHR2401

Timeline

• Start date: 2025-01-11
• Primary completion: 2025-01-20
• Completion: 2025-01-21
• First posted: 2025-01-15
• Last updated: 2025-02-03

Locations

1 site across 1 country: South Korea