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Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-30061
Exforge® 5/160mg & Lipitor® 20mg
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence 1(RTR)

Sequence 2(RRT)

Sequence 3(TRR)

Arm Description

Outcomes

Primary Outcome Measures

Cmax of amlodipine
Cmax of valsartan
Cmax of atorvastatin
AUCt of amlodipine
AUCt of valsartan
AUCt of atorvastatin

Secondary Outcome Measures

tmax of amlodipine
tmax of valsartan
tmax of atorvastatin
t1/2 of atorvastatin
t1/2 of amlodipine
t1/2 of valsartan
AUCinf of amlodipine
AUCinf of valsartan
AUCinf of atorvastatin
AUCt of 2-OH atorvastatin
Cmax of 2-OH atorvastatin
tmax of 2-OH atorvastatin
t1/2 of 2-OH atorvastatin
AUCinf of 2-OH atorvastatin

Full Information

First Posted
August 9, 2018
Last Updated
September 2, 2018
Sponsor
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03657472
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
October 29, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1(RTR)
Arm Type
Experimental
Arm Title
Sequence 2(RRT)
Arm Type
Experimental
Arm Title
Sequence 3(TRR)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CJ-30061
Intervention Description
Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
Intervention Type
Drug
Intervention Name(s)
Exforge® 5/160mg & Lipitor® 20mg
Intervention Description
Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Primary Outcome Measure Information:
Title
Cmax of amlodipine
Time Frame
Up to 72 hours
Title
Cmax of valsartan
Time Frame
Up to 72 hours
Title
Cmax of atorvastatin
Time Frame
Up to 72 hours
Title
AUCt of amlodipine
Time Frame
Up to 72 hours
Title
AUCt of valsartan
Time Frame
Up to 72 hours
Title
AUCt of atorvastatin
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
tmax of amlodipine
Time Frame
Up to 72 hours
Title
tmax of valsartan
Time Frame
Up to 72 hours
Title
tmax of atorvastatin
Time Frame
Up to 72 hours
Title
t1/2 of atorvastatin
Time Frame
Up to 72 hours
Title
t1/2 of amlodipine
Time Frame
Up to 72 hours
Title
t1/2 of valsartan
Time Frame
Up to 72 hours
Title
AUCinf of amlodipine
Time Frame
Up to 72 hours
Title
AUCinf of valsartan
Time Frame
Up to 72 hours
Title
AUCinf of atorvastatin
Time Frame
Up to 72 hours
Title
AUCt of 2-OH atorvastatin
Time Frame
Up to 72 hours
Title
Cmax of 2-OH atorvastatin
Time Frame
Up to 72 hours
Title
tmax of 2-OH atorvastatin
Time Frame
Up to 72 hours
Title
t1/2 of 2-OH atorvastatin
Time Frame
Up to 72 hours
Title
AUCinf of 2-OH atorvastatin
Time Frame
Up to 72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeWook Ko, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

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