Status:
COMPLETED
Clinical Trial to Investigate the Efficacy and Safety of DWJ1351
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
Detailed Description
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.
Eligibility Criteria
Inclusion
- Subject who provided written informed consent to participate in this study
- Healthy adult male subjects aged 19 to 50 years
- Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
- Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
Exclusion
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- Subjects who had a serious clinical illness that can impact fate of drugs absorption
- Subject who shows vital signs with the number of systolic blood pressure of \>140 mmHg or \<100 mmHg, and the number of diastolic blood pressure of \>90mmHg or \<65mmHg
- Subject who have experienced drug abuse
- Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
- Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03753477
Start Date
December 22 2017
End Date
February 1 2018
Last Update
November 28 2018
Active Locations (1)
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1
Busan Paik Hospital
Busan, South Korea