NCT06318845

Phase 1 Study of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interaction of DHP2302R1 and DHP2302R2 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Daehwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants.

Detailed description

This is a phase 1 open-label, multiple doses, 6-sequence, 3-period, and crossover study to evaluate the safety and pharmacokinetic drug interaction following 7 days of DHP2302R1 75 mg and DHP2302R2 50 mg in healthy South Korean adult participants. A total of 42 participants, 7 per 6 groups, will enroll in the study. The participants will take 7 days of DHP2302R1 75 mg, DHP2302R1 50 mg alone or in combination, and 2 weeks of washout period at each period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DHP2302R1	75 mg per dose, once daily
DRUG	DHP2302R2	50 mg per dose, once daily

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-04-26
• Completion: 2024-05-07
• First posted: 2024-03-19
• Last updated: 2024-07-25

Locations

1 site across 1 country: South Korea