- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03639493
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
August 19, 2018 updated by: HK inno.N Corporation
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Korea University Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males aged 20 to 45 years at screening
- BMI: 18 ~ 29.9kg/m^2
- Body weight ≥ 50kg
- Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Exclusion Criteria:
- Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
- Subjects who have symptoms of an acute disease within 28 days before first administration
- Subjects who have clinically significant active, chronic disease
Subjects who fall under the criteria below in laboratory test
- AST/ALT > UNL (upper normal limit) x 2
- Total bilirubin > UNL x 1.5
- CrCL < 50mL/min
- CPK > UNL x 2.5
- Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
- Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1
|
Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
|
Experimental: Sequence 2
|
Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax of amlodipine
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
Cmax of valsartan
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
Cmax of rosuvastatin
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
AUClast of amlodipine
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
AUClast of valsartan
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
AUClast of rosuvastatin
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinf of amlodipine, valsaran, rosuvastatin
Time Frame: Up to 144 hours post-dose
|
Up to 144 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji Young Park, PhD, Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2018
Primary Completion (Actual)
May 4, 2018
Study Completion (Actual)
May 17, 2018
Study Registration Dates
First Submitted
August 9, 2018
First Submitted That Met QC Criteria
August 19, 2018
First Posted (Actual)
August 21, 2018
Study Record Updates
Last Update Posted (Actual)
August 21, 2018
Last Update Submitted That Met QC Criteria
August 19, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CJ_EXR_103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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