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

January 14, 2019 updated by: Yuhan Corporation

A Randomized, Open-label, Single Dose, Replicate Crossover 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollanam-do
      • Jeonju, Jeollanam-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Study drug
Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet
Other Names:
  • 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 Names:
  • Study drug
Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet
Other Names:
  • Comparator drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUClast of Telmisartan/amlodipine/chlorthalidone
Time Frame: 0-168 hrs
AUClast
0-168 hrs
Cmax of Telmisartan/amlodipine/chlorthalidone
Time Frame: 0-168 hrs
Cmax
0-168 hrs

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Mingul Kim, MD, Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2018

Primary Completion (Actual)

December 8, 2018

Study Completion (Actual)

December 22, 2018

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH22162-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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