Status:
COMPLETED
The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy Male Volunteer
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
To investigate the pharmacokinetic Drug-drug interaction
Detailed Description
The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.
Eligibility Criteria
Inclusion
- Healthy male volunteers aged 19 to 50
- Participant who has a body weight that is \>=55kg(male) and body mass index (BMI) level that is 18\~30
- Provision of signed written informed consent
Exclusion
- History of clinically significant disease
- History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 2 months prior to the first dosing.
- Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study)
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02233218
Start Date
July 1 2014
End Date
January 1 2015
Last Update
February 18 2015
Active Locations (1)
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1
Dong-A university hospital
Pusan, South Korea