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Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
Who has not suffered from clinically significant disease
Provision of signed written informed consent

Exclusion Criteria:

History of and clinically significant disease
Administration of other investigational products within 3 months prior to the first dosing
Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Sites / Locations

Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ARM1

ARM2

Arm Description

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Outcomes

Primary Outcome Measures

AUClast of Telmisartan/amlodipine/chlorthalidone

AUClast

Cmax of Telmisartan/amlodipine/chlorthalidone

Cmax

Secondary Outcome Measures

AUCinf of Telmisartan/amlodipine/chlorthalidone

AUCinf

Tmax of Telmisartan/amlodipine/chlorthalidone

Tmax

t1/2 of Telmisartan/amlodipine/chlorthalidone

t1/2

Full Information

NCT ID

NCT03662620

First Posted

September 3, 2018

Last Updated

January 14, 2019

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03662620

Brief Title

Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Official Title

A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 5, 2018 (Actual)

Primary Completion Date

December 8, 2018 (Actual)

Study Completion Date

December 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers. Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.

Detailed Description

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64. In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM1

Arm Type

Experimental

Arm Description

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

Arm Title

ARM2

Arm Type

Experimental

Arm Description

In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Intervention Type

Drug

Intervention Name(s)

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Other Intervention Name(s)

Study drug

Intervention Description

White colored oval three-layer tablet

Intervention Type

Drug

Intervention Name(s)

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Other Intervention Name(s)

Comparator drug

Intervention Description

White and pink colored oval two-layer tablet

Primary Outcome Measure Information:

Title

AUClast of Telmisartan/amlodipine/chlorthalidone

Description

AUClast

Time Frame

0-168 hrs

Title

Cmax of Telmisartan/amlodipine/chlorthalidone

Description

Cmax

Time Frame

0-168 hrs

Secondary Outcome Measure Information:

Title

AUCinf of Telmisartan/amlodipine/chlorthalidone

Description

AUCinf

Time Frame

0-168 hrs

Title

Tmax of Telmisartan/amlodipine/chlorthalidone

Description

Tmax

Time Frame

0-168 hrs

Title

t1/2 of Telmisartan/amlodipine/chlorthalidone

Description

t1/2

Time Frame

0-168 hrs

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease Administration of other investigational products within 3 months prior to the first dosing Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingul Kim, MD

Organizational Affiliation

Chonbuk National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonbuk National University Hospital

City

Jeonju

State/Province

Jeollanam-do

ZIP/Postal Code

54907

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

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