Clinical trial NCT03657472: Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
Official title: An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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)

Primary outcomes:
measure: Cmax of amlodipine
timeFrame: Up to 72 hours
measure: Cmax of valsartan
timeFrame: Up to 72 hours
measure: Cmax of atorvastatin
timeFrame: Up to 72 hours
measure: AUCt of amlodipine
timeFrame: Up to 72 hours
measure: AUCt of valsartan
timeFrame: Up to 72 hours
measure: AUCt of atorvastatin
timeFrame: Up to 72 hours
Secondary outcomes:
measure: tmax of amlodipine
timeFrame: Up to 72 hours
measure: tmax of valsartan
timeFrame: Up to 72 hours
measure: tmax of atorvastatin
timeFrame: Up to 72 hours
measure: t1/2 of atorvastatin
timeFrame: Up to 72 hours
measure: t1/2 of amlodipine
timeFrame: Up to 72 hours
measure: t1/2 of valsartan
timeFrame: Up to 72 hours
measure: AUCinf of amlodipine
timeFrame: Up to 72 hours
measure: AUCinf of valsartan
timeFrame: Up to 72 hours
measure: AUCinf of atorvastatin
timeFrame: Up to 72 hours
measure: AUCt of 2-OH atorvastatin
timeFrame: Up to 72 hours
measure: Cmax of 2-OH atorvastatin
timeFrame: Up to 72 hours
measure: tmax of 2-OH atorvastatin
timeFrame: Up to 72 hours
measure: t1/2 of 2-OH atorvastatin
timeFrame: Up to 72 hours
measure: AUCinf of 2-OH atorvastatin
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: JaeWook Ko, PhD
role: PRINCIPAL_INVESTIGATOR
References: