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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662620
• Other study ID #: YH22162-103
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2018
• Est. completion date: December 22, 2018

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 22, 2018
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White colored oval three-layer tablet
• Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast of Telmisartan/amlodipine/chlorthalidone	AUClast	0-168 hrs
Primary	Cmax of Telmisartan/amlodipine/chlorthalidone	Cmax	0-168 hrs
Secondary	AUCinf of Telmisartan/amlodipine/chlorthalidone	AUCinf	0-168 hrs
Secondary	Tmax of Telmisartan/amlodipine/chlorthalidone	Tmax	0-168 hrs
Secondary	t1/2 of Telmisartan/amlodipine/chlorthalidone	t1/2	0-168 hrs