NCT05688085

Brief Summary

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

January 8, 2023

Last Update Submit

August 15, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • AUCt of Irbesartan High and Amlodipine

    72 hours

  • Cmax of Irbesartan High and Amlodipine

    72 hours

Secondary Outcomes (6)

  • AUCinf of Irbesartan High and Amlodipine

    72 hours

  • AUCt/AUCinf of Irbesartan High and Amlodipine

    72 hours

  • tmax of Irbesartan High and Amlodipine

    72 hours

  • half-life of Irbesartan High and Amlodipine

    72 hours

  • CL/F of Irbesartan High and Amlodipine

    72 hours

  • +1 more secondary outcomes

Study Arms (2)

Irbesartan High/Amlodipine Fixed dose combination

EXPERIMENTAL

participants will receive one tablet of Irbesartan High/Amlodipine FDC in a crossover design

Drug: Irbesartan High/Amlodipine FDC

Co-administration of Irbesartan High and Amlodipine

EXPERIMENTAL

participants will receive one table each of Irbesartan High and Amlodipine in a crossover design

Drug: Irbesartan HighDrug: Amlodipine

Interventions

Irbesartan High/Amlodipine FDCDRUG

Irbesartan High/Amlodipine FDC

Irbesartan High/Amlodipine Fixed dose combination
Irbesartan HighDRUG

Co-administration of Irbesartan High and Amlodipine

Co-administration of Irbesartan High and Amlodipine
AmlodipineDRUG

Co-administration of Irbesartan High and Amlodipine

Co-administration of Irbesartan High and Amlodipine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 19 years or older on screening
  • Signed informed consent
  • Healthy Volunteer

You may not qualify if:

  • Clinically relevant/significant findings as evaluated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

October 18, 2022

Primary Completion

December 29, 2022

Study Completion

April 21, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

KR(1)