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

Phase 1

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: HUC2-565-A, HUC2-565-A and HUC2-565-B; Drug: HUC2-565-B, HUC2-565-A and HUC2-565-B

• Registration Number: NCT06618079
• Lead Sponsor: Huons Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2024-04-20
• Study First Submitted: 2024-04-22
• Primary Completion: 2024-07-12
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	HUC2-565-A, HUC2-565-A and HUC2-565-B	Evaluate the effect of S-Amlodipine on the pharmacokinetic properties of Azilsartan under steady states.
Cohort B	HUC2-565-B, HUC2-565-A and HUC2-565-B	Evaluate the effect of Azilsartan on the pharmacokinetic properties of S-amlodipine under steady states.

Primary Outcome Measures

Name	Time	Method
AUCtau,ss	0-14days	Pharmacokinetic parameter
Cmax,ss	0-14days	Pharmacokinetic parameter

Secondary Outcome Measures

Name	Time	Method
T1/2,ss	0-14days	Pharmacokinetic parameter
CLss/F	0-14days	Pharmacokinetic parameter
AUCinf,ss	0-14days	Pharmacokinetic parameter
Tmax,ss	0-14days	Pharmacokinetic parameter
Vdss/F	0-14days	Pharmacokinetic parameter
Cmin,ss	0-14days	Pharmacokinetic parameter
Cav,ss	0-14days	Pharmacokinetic parameter
PTF(Peak-to-trough fluctuation)	0-14days	Pharmacokinetic parameter
Metabolic ratio	0-14days	Pharmacokinetic parameter

Trial Locations

Locations (1)

Chungbuk national university hospital; 🇰🇷 Chungbuk, Korea, Republic of