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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

• Registration Number: NCT03662620
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-10-05
• Primary Completion: 2018-12-08
• Study Completion: 2018-12-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM2	Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg	In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
ARM1	Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg	In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

Primary Outcome Measures

Name	Time	Method
Cmax of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	Cmax
AUClast of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	AUClast

Secondary Outcome Measures

Name	Time	Method
t1/2 of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	t1/2
AUCinf of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	AUCinf
Tmax of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	Tmax

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollanam-do, Korea, Republic of