NCT05737082

A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2201 and Co-administration of RLD2205 and RLD2206 in Healthy Male Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HCP2201	Take 2 tablets once per period
DRUG	RLD2205	Take 2 tablets once per period
DRUG	RLD2206	Take 1 tablet once per period

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-05-14
• Completion: 2023-05-14
• First posted: 2023-02-21
• Last updated: 2024-03-05

Locations

1 site across 1 country: South Korea