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

Primary Purpose

Hypertension, Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Twynsta 80/5mg

Crestor 20mg

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Twynsta 80/5mg

Crestor 20mg

Arm Description

Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Outcomes

Primary Outcome Measures

Telmisartan, Amlodipine, Rosuvastatin AUCτ

Telmisartan, Amlodipine, Rosuvastatin Cmax

Secondary Outcome Measures

Telmisartan, Amlodipine, Rosuvastatin Tmax

Telmisartan, Amlodipine, Rosuvastatin Cmin

Full Information

NCT ID

NCT02951962

First Posted

August 21, 2016

Last Updated

January 31, 2017

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02951962

Brief Title

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

Official Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Twynsta 80/5mg

Arm Type

Experimental

Arm Description

Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Arm Title

Crestor 20mg

Arm Type

Experimental

Arm Description

Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Intervention Type

Drug

Intervention Name(s)

Twynsta 80/5mg

Other Intervention Name(s)

Telmisartan/Amlodipine 80/5mg

Intervention Description

Hypertension

Intervention Type

Drug

Intervention Name(s)

Crestor 20mg

Other Intervention Name(s)

Rosuvastatin 20mg

Intervention Description

Hyperlipidemia

Primary Outcome Measure Information:

Title

Telmisartan, Amlodipine, Rosuvastatin AUCτ

Time Frame

0 - 24 hr

Title

Telmisartan, Amlodipine, Rosuvastatin Cmax

Time Frame

0 - 24 hr

Secondary Outcome Measure Information:

Title

Telmisartan, Amlodipine, Rosuvastatin Tmax

Time Frame

0 - 24 hr

Title

Telmisartan, Amlodipine, Rosuvastatin Cmin

Time Frame

0 - 24 hr

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min-Gul Kim

Organizational Affiliation

Chonbuk National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonbuk National University Hospital

City

Chunju

ZIP/Postal Code

561-712

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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