Back to resultsPharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
Primary Purpose
Hypertension, Hyperlipidemias
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-30060
Exforge tab 5/160mg, Crestor tab 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
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.
Sites / Locations
- Korea University Anam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CJ-30060
Exforge tab 5/160mg, Crestor tab 10mg
Arm Description
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
Half life (t1/2) of amlodipine, valsartan, rosuvastatin
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03009474
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CJ-30060
Arm Type
Experimental
Arm Description
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Arm Title
Exforge tab 5/160mg, Crestor tab 10mg
Arm Type
Active Comparator
Arm Description
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Intervention Type
Drug
Intervention Name(s)
CJ-30060
Intervention Description
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
Intervention Type
Drug
Intervention Name(s)
Exforge tab 5/160mg, Crestor tab 10mg
Intervention Description
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
Title
Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
Title
Half life (t1/2) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
Title
Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
Title
Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
Time Frame
Up to 144 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Young Park, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
We'll reach out to this number within 24 hrs