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Keep this study
Lead
HK inno.N Corporation
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Age
20–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Healthy male aged 20 to 45 years at the screening
Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
You may not be if
Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
Subject who have symptoms, result from acute disease within 28days before first administration.
Subject who have chronic persisting disease with clinical significance.
Subject who fall under the criteria below in laboratory test.
* AST/ALT \> UNL (upper normal limit) x 2
* Total bilirubin \> UNL x 1.5
* In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
* CPK \> UNL x 2.5
Subject who with low blood pressure with clinical significance at screening test.
(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)
Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.
Clareo Health | Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
