Status:
COMPLETED
Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Hypertension With Hyperlipidemia
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers
Eligibility Criteria
Inclusion
- 19\~55 years healthy male
- 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
- 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 ≤ 70mmHg)
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Key Trial Info
Start Date :
May 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03461081
Start Date
May 7 2017
End Date
December 12 2017
Last Update
March 12 2018
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea