An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- HK inno.N Corporation
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Cmax of amlodipine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Sequence 1
- period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
- period 2: receive CJ-30060 5/160/10mg
Intervention: Exforge® tab 5/160mg, Crestor® tab 10mg (Drug)
Sequence 1
- period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
- period 2: receive CJ-30060 5/160/10mg
Intervention: CJ-30060 5/160/10mg (Drug)
Sequence 2
- period 1: receive CJ-30060 5/160/10mg
- period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
Intervention: Exforge® tab 5/160mg, Crestor® tab 10mg (Drug)
Sequence 2
- period 1: receive CJ-30060 5/160/10mg
- period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
Intervention: CJ-30060 5/160/10mg (Drug)
Outcomes
Primary Outcomes
Cmax of amlodipine
Time Frame: Up to 144 hours post-dose
Cmax of rosuvastatin
Time Frame: Up to 72 hours post-dose
AUClast of valsartan
Time Frame: Up to 48 hours post-dose
Cmax of valsartan
Time Frame: Up to 48 hours post-dose
AUClast of amlodipine
Time Frame: Up to 144 hours post-dose
AUClast of rosuvastatin
Time Frame: Up to 72 hours post-dose
Secondary Outcomes
- AUCinf of amlodipine, valsartan, rosuvastatin(Up to 144 hours post-dose)