Status:
COMPLETED
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Hypertension With Dyslipidemia
Eligibility:
MALE
19+ years
Phase:
PHASE1
Brief Summary
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
Eligibility Criteria
Inclusion
- Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Exclusion
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Subjects who are allergic to investigational drug.
- Subjects who have a medical history which can affect the clinical trial.
- Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
- AST or ALT \> X 2 UNL
- History of drug abuse or positive drug screening.
- Participation in other drug studies within 3 months prior to the drug administration.
- Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Key Trial Info
Start Date :
June 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03247140
Start Date
June 10 2017
End Date
November 27 2017
Last Update
December 26 2017
Active Locations (1)
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1
Chonbuk National University Hospital
Jeonju, South Korea