Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
NCT ID: NCT03461081
Last Updated: 2018-03-12
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
32 participants
INTERVENTIONAL
2017-05-07
2017-12-12
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 I
Period I: administration of telmisartan/Amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days Period II: atorvastatin for 4 days
telmisartan/amlodipine and atorvastatin
Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
Group II
Period I: administration of atorvastatin for 4 days Period II: administration of telmisartan/amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days
telmisartan/amlodipine and atorvastatin
Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
Interventions
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telmisartan/amlodipine and atorvastatin
Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
Eligibility Criteria
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Inclusion Criteria
* The result of Body Mass Index(BMI) is not less than 19 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 ≤ 70mmHg)
* 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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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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JLP-1610-101-DDI
Identifier Type: -
Identifier Source: org_study_id
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