NCT06618079

Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B

A Two Cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of HUC2-565-A and HUC2-565-B in Healthy Adult Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Huons Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety.

Detailed description

Cohort A: To evaluate the effect of S-Amlodipine on the pharmacokinetics of Azilsartan at steady state. Cohort B: To evaluate the effect of Azilsartan on the pharmacokinetics of S-Amlodipine at steady state.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	HUC2-565-A, HUC2-565-A and HUC2-565-B	Cohort A received HUC2-565-A for 5 days, followed by HUC2-565-A and HUC2-565-B for 9 days.
DRUG	HUC2-565-B, HUC2-565-A and HUC2-565-B	Cohort B takes HUC2-565-B for 9 days, then HUC2-565-A and HUC2-565-B for 5 days.

Timeline

• Start date: 2024-04-20
• Primary completion: 2024-07-12
• Completion: 2024-10-01
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: South Korea