PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

January 31, 2017 updated by: Yuhan Corporation

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three 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 YH22189 FDC or telmisartan/amlodipine or rosuvastatin 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 three treatment periods will be separated by a washout period.

Study Type

Interventional

Enrollment (Actual)

123

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing
  • Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
  • 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YH22189
YH22189 FDC tablet of Yuhan Corporation
Drug: YH22189
Active Comparator: Twynsta 80/10mg
Telmisartan/Amlodipine 80/10mg (FDC)
Drug: Twynsta 80/10mg
Other Names:
  • Telmisartan/Amlodipine 80/10mg(FDC)
Active Comparator: Crestor 20mg
Rosuvastatin 20mg
Drug: Crestor 20mg
Other Names:
  • Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telmisartan Cmax
Time Frame: 0 - 72 hrs
0 - 72 hrs
Telmisartan AUClast
Time Frame: 0 - 72 hrs
0 - 72 hrs
Amlodipine Cmax
Time Frame: 0 - 168 hrs
0 - 168 hrs
Amlodipine AUClast
Time Frame: 0 - 168 hrs
0 - 168 hrs
Rosuvastatin Cmax
Time Frame: 0 - 48 hrs
0 - 48 hrs
Rosuvastatin AUClast
Time Frame: 0 - 48 hrs
0 - 48 hrs

Collaborators and Investigators

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

Sponsor

Yuhan Corporation

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)

November 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH22189-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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