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Completed

NCT Number: NCT03662620

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, Jeollanam-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Drug

White colored oval three-layer tablet

Other names: Study drug

Primary outcomes

  1. AUClast of Telmisartan/amlodipine/chlorthalidone

    Time frame: 0-168 hrs

    AUClast

  2. Cmax of Telmisartan/amlodipine/chlorthalidone

    Time frame: 0-168 hrs

    Cmax

Secondary outcomes

  1. AUCinf of Telmisartan/amlodipine/chlorthalidone

    Time frame: 0-168 hrs

    AUCinf

  2. Tmax of Telmisartan/amlodipine/chlorthalidone

    Time frame: 0-168 hrs

    Tmax

  3. t1/2 of Telmisartan/amlodipine/chlorthalidone

    Time frame: 0-168 hrs

    t1/2

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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