A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

January 31, 2017 updated by: Yuhan Corporation

A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

This is a phase 1, open label, two-cohort, single-sequence, crossover study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

Study Type

Interventional

Enrollment (Anticipated)

60

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 with body mass index(BMI) between 18.5 and 28 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 due to reasons including laboratory test results, ECGs, or vital signs
  • Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ 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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Twynsta 80/5mg
Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Drug: Twynsta 80/5mg
Hypertension
Other Names:
  • Telmisartan/Amlodipine 80/5mg
Drug: Crestor 20mg
Hyperlipidemia
Other Names:
  • Rosuvastatin 20mg
Experimental: Crestor 20mg
Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Drug: Twynsta 80/5mg
Hypertension
Other Names:
  • Telmisartan/Amlodipine 80/5mg
Drug: Crestor 20mg
Hyperlipidemia
Other Names:
  • Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telmisartan, Amlodipine, Rosuvastatin AUCτ
Time Frame: 0 - 24 hr
0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin Cmax
Time Frame: 0 - 24 hr
0 - 24 hr

Secondary Outcome Measures

Outcome Measure
Time Frame
Telmisartan, Amlodipine, Rosuvastatin Tmax
Time Frame: 0 - 24 hr
0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin Cmin
Time Frame: 0 - 24 hr
0 - 24 hr

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)

August 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

October 30, 2016

First Posted (Estimate)

November 1, 2016

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

  • YHP1604-101

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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