- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387619
The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
June 23, 2016 updated by: Jeil Pharmaceutical Co., Ltd.
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
- Yonsei University Health System
-
-
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
17 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
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: Group 1 of part 1
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 once daily for 9 days
Other Names:
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other Names:
|
Experimental: Group 2 of part 1
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: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other Names:
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Other Names:
|
Experimental: Group 1 of part 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 once daily for 9 days
Other Names:
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other Names:
|
Experimental: Group 2 of part 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
|
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other Names:
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Time Frame: 72hours, 144hours
|
72hours, 144hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast,ss of Rosuvastatin
Time Frame: 72hours
|
72hours
|
AUCinf,ss of Rosuvastatin
Time Frame: 72hours
|
72hours
|
Tmax,ss of Rosuvastatin
Time Frame: 72hours
|
72hours
|
t1/2 of Rosuvastatin
Time Frame: 72hours
|
72hours
|
AUClast,ss of Telmisartan, Amlodipine
Time Frame: 144hours
|
144hours
|
AUCinf,ss of Telmisartan, Amlodipine
Time Frame: 144hours
|
144hours
|
Tmax,ss of Telmisartan, Amlodipine
Time Frame: 144hours
|
144hours
|
t1/2 of Telmisartan, Amlodipine
Time Frame: 144hours
|
144hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyungsoo Park, MD, Ph.D., Yonsei University
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
February 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Estimate)
June 24, 2016
Last Update Submitted That Met QC Criteria
June 23, 2016
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Rosuvastatin Calcium
- Telmisartan
- Telmisartan amlodipine combination
Other Study ID Numbers
- JLP-1401-P1-DI
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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