NCT04316065

Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg

A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers

Detailed description

30 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8. Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	YHP1906	YHP1906 Tab. 5 mg
DRUG	YHR1902	Comparator. YHR1902 Tab. 5 mg

Timeline

• Start date: 2020-04-11
• Primary completion: 2020-04-20
• Completion: 2020-04-24
• First posted: 2020-03-20
• Last updated: 2020-05-26

Locations

1 site across 1 country: South Korea