NCT07470125

Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A 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 "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" and "comparator" by crossover design on period 1, 2.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	YHP2511	Test drug: YHP2511, Comparator: YHP2511A
DRUG	YHP2511A	Test drug: YHP2511, Comparator: YHP2511A

Timeline

• Start date: 2026-06-23
• Primary completion: 2026-07-11
• Completion: 2026-07-11
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: South Korea