Clinical trial NCT03009474: Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 52
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male 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 male volunteers.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
measure: Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
measure: Half life (t1/2) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
measure: Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
measure: Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
timeFrame: Up to 144 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji Young Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: