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

Yuhan

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03662620

YH22162-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts 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