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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662620
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : December 8, 2018
Actual Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM1
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White colored oval three-layer tablet
Other Name: Study drug

Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet
Other Name: Comparator drug

Experimental: ARM2
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White colored oval three-layer tablet
Other Name: Study drug

Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet
Other Name: Comparator drug




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662620


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollanam-do, Korea, Republic of, 54907
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Mingul Kim, MD Chonbuk National University Hospital
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03662620    
Other Study ID Numbers: YH22162-103
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Chlorthalidone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors