The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
NCT ID: NCT02387619
Last Updated: 2016-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2015-02-28
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
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
Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
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
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
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
Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Interventions
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Rosuvastatin
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
55 Years
MALE
Yes
Sponsors
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Jeil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kyungsoo Park, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Yonsei University Health System
Seoul, Seodaemun-gu, South Korea
Countries
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Other Identifiers
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JLP-1401-P1-DI
Identifier Type: -
Identifier Source: org_study_id
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