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Clinical Trials/NCT06618079
NCT06618079
Active, not recruiting
Phase 1

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

Huons Co., Ltd.1 site in 1 country46 target enrollmentApril 20, 2024
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ConditionsHypertension
InterventionsHUC2-565-A, HUC2-565-A and HUC2-565-BHUC2-565-B, HUC2-565-A and HUC2-565-B
DrugsHUC2-565-A, HUC2-565-A and HUC2-565-BHUC2-565-B, HUC2-565-A and HUC2-565-B

Overview

Phase
Phase 1
Intervention
HUC2-565-A, HUC2-565-A and HUC2-565-B
Conditions
Hypertension
Sponsor
Huons Co., Ltd.
Enrollment
46
Locations
1
Primary Endpoint
AUCtau,ss
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
October 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Cohort A

Evaluate the effect of S-Amlodipine on the pharmacokinetic properties of Azilsartan under steady states.

Intervention: HUC2-565-A, HUC2-565-A and HUC2-565-B

Cohort B

Evaluate the effect of Azilsartan on the pharmacokinetic properties of S-amlodipine under steady states.

Intervention: HUC2-565-B, HUC2-565-A and HUC2-565-B

Outcomes

Primary Outcomes

AUCtau,ss

Time Frame: 0-14days

Pharmacokinetic parameter

Cmax,ss

Time Frame: 0-14days

Pharmacokinetic parameter

Secondary Outcomes

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

Study Sites (1)

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