PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

September 24, 2015 updated by: Yuhan Corporation

A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers

This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.

Study Type

Interventional

Enrollment (Anticipated)

180

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
      • Chunju, Korea, Republic of, 561-712
        • 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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
  2. Who has not suffered from clinically significant disease
  3. Provision of signed written informed consent

Exclusion Criteria:

  1. History of and clinically significant disease
  2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
  3. Administration of other investigational products within 3 months prior to the first dosing.
  4. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
  5. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 - Period 1
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Drug: Chlorthalidone 25mg
Other Names:
  • Hygroton 25mg
Drug: Telmisartan/Amlodipine 80/5 mg (FDC)
Other Names:
  • Twinstar 80/5 mg
Experimental: Group 2 - Period 1
YH22162 FDC tablet of Yuhan Corporation
Drug: YH22162
Experimental: Group 1 - Period 2
YH22162 FDC tablet of Yuhan Corporation
Drug: YH22162
Active Comparator: Group 2 - Period 2
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Drug: Chlorthalidone 25mg
Other Names:
  • Hygroton 25mg
Drug: Telmisartan/Amlodipine 80/5 mg (FDC)
Other Names:
  • Twinstar 80/5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence study is based on Cmax and AUC parameters
Time Frame: 1 month
1 month

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, Ph.D, 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

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH22162-102

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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