Status:
UNKNOWN
Bioequivalence Study of CJ-30060 in Healthy Volunteers
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.
Detailed Description
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 volunteers.
Eligibility Criteria
Inclusion
- Healthy volunteers aged 20 to 45 years at screening
- BMI: 18\~29.9kg/㎡
- Body weight ≥50kg
- Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Exclusion
- Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
- Subjects who have symptoms of an acute disease within 28days before first administration
- Subjects who have clinically significant active, chronic disease
- Subjects who fall under the criteria below in laboratory test
- AST/ALT \> UNL (upper normal limit) × 2
- Total bilirubin \> UNL × 1.5
- CrCL \< 50mL/min
- CPK \> UNL × 2.5
- Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)
- Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests
Key Trial Info
Start Date :
November 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03757390
Start Date
November 9 2018
End Date
December 14 2018
Last Update
November 28 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Anam Hospital
Seoul, South Korea