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The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 19~55 years healthy male
  • Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
  • Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Sites / Locations

  • Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 of part 1

Group 2 of part 1

Group 1 of part 2

Group 2 of part 2

Arm Description

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Outcomes

Primary Outcome Measures

AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine

Secondary Outcome Measures

AUClast,ss of Rosuvastatin
AUCinf,ss of Rosuvastatin
Tmax,ss of Rosuvastatin
t1/2 of Rosuvastatin
AUClast,ss of Telmisartan, Amlodipine
AUCinf,ss of Telmisartan, Amlodipine
Tmax,ss of Telmisartan, Amlodipine
t1/2 of Telmisartan, Amlodipine

Full Information

First Posted
March 9, 2015
Last Updated
June 23, 2016
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02387619
Brief Title
The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Official Title
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
Detailed Description
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

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
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 of part 1
Arm Type
Experimental
Arm Description
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Arm Title
Group 2 of part 1
Arm Type
Experimental
Arm Description
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Arm Title
Group 1 of part 2
Arm Type
Experimental
Arm Description
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
Arm Title
Group 2 of part 2
Arm Type
Experimental
Arm Description
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Amlodipine
Other Intervention Name(s)
Twynsta
Intervention Description
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin and Telmisartan/Amlodipine
Other Intervention Name(s)
Crestor and Twynsta
Intervention Description
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Primary Outcome Measure Information:
Title
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Time Frame
72hours, 144hours
Secondary Outcome Measure Information:
Title
AUClast,ss of Rosuvastatin
Time Frame
72hours
Title
AUCinf,ss of Rosuvastatin
Time Frame
72hours
Title
Tmax,ss of Rosuvastatin
Time Frame
72hours
Title
t1/2 of Rosuvastatin
Time Frame
72hours
Title
AUClast,ss of Telmisartan, Amlodipine
Time Frame
144hours
Title
AUCinf,ss of Telmisartan, Amlodipine
Time Frame
144hours
Title
Tmax,ss of Telmisartan, Amlodipine
Time Frame
144hours
Title
t1/2 of Telmisartan, Amlodipine
Time Frame
144hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 19~55 years healthy male Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2 Subjects who agree to keep contraceptive methods during the clinical trial. Exclusion Criteria: Subjects who are allergic to investigational drug. Subjects who have a medical history which can affect the clinical trial. Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg) Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungsoo Park, MD, Ph.D.
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

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