Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co... | NCT05688085

Studies
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers

NCT05688085

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Aug 18, 2023Actual

Enrollment

44Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Irbesartan High/Amlodipine FDC
Irbesartan High
Amlodipine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2022Actual

Primary Completion Date

Dec 29, 2022Actual

Completion Date

Apr 21, 2023Actual

First Submitted Date

Jan 8, 2023

First Submission Date that Met QC Criteria

Jan 8, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2023

Last Update Posted Date

Aug 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 High Drug: Amlodipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan High/Amlodipine FDC	Drug	Irbesartan High/Amlodipine FDC	Irbesartan High/Amlodipine Fixed dose combination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt of Irbesartan High and Amlodipine		72 hours
Cmax of Irbesartan High and Amlodipine		72 hours

Secondary Outcomes

Measure	Description	Time Frame
AUCinf of Irbesartan High and Amlodipine		72 hours
AUCt/AUCinf of Irbesartan High and Amlodipine		72 hours
tmax of Irbesartan High and Amlodipine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are 19 years or older on screening
Signed informed consent
Healthy Volunteer
Other inclusion applied

Exclusion Criteria:

Clinically relevant/significant findings as evaluated by the investigator
Other exclusion applied

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H Plus Yangji Hospital		Seoul		08779	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D017311	Amlodipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided