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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03662620

Enrollment

Registered

2018-09-07

Start date

2018-10-05

Completion date

2018-12-22

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGTelmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

White colored oval three-layer tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUClast of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	AUClast
Cmax of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	Cmax

Secondary

Measure	Time frame	Description
AUCinf of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	AUCinf
Tmax of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	Tmax
t1/2 of Telmisartan/amlodipine/chlorthalidone	0-168 hrs	t1/2

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026