Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- HyperlipidemiaHypertension
- Interventions
- Registration Number
- NCT03657472
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
- Healthy male aged 19 to 55 years at the time of signing informed consent form.
- Subject with BMI from 19kg/m^2 to 27kg/m^2
- Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study
Exclusion Criteria
-
Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
-
Subject who fall under the criteria below in laboratory test.
- AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
- CPK > UNL x 2.5
- CrCL < 60mL/min
-
Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1(RTR) Exforge® 5/160mg & Lipitor® 20mg - Sequence 3(TRR) Exforge® 5/160mg & Lipitor® 20mg - Sequence 2(RRT) Exforge® 5/160mg & Lipitor® 20mg - Sequence 1(RTR) CJ-30061 - Sequence 2(RRT) CJ-30061 - Sequence 3(TRR) CJ-30061 -
- Primary Outcome Measures
Name Time Method AUCt of valsartan Up to 72 hours Cmax of valsartan Up to 72 hours Cmax of amlodipine Up to 72 hours Cmax of atorvastatin Up to 72 hours AUCt of atorvastatin Up to 72 hours AUCt of amlodipine Up to 72 hours
- Secondary Outcome Measures
Name Time Method t1/2 of 2-OH atorvastatin Up to 72 hours AUCinf of 2-OH atorvastatin Up to 72 hours AUCinf of atorvastatin Up to 72 hours t1/2 of amlodipine Up to 72 hours tmax of valsartan Up to 72 hours t1/2 of atorvastatin Up to 72 hours AUCinf of amlodipine Up to 72 hours tmax of amlodipine Up to 72 hours tmax of atorvastatin Up to 72 hours t1/2 of valsartan Up to 72 hours AUCinf of valsartan Up to 72 hours AUCt of 2-OH atorvastatin Up to 72 hours tmax of 2-OH atorvastatin Up to 72 hours Cmax of 2-OH atorvastatin Up to 72 hours
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of