- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501200
CKD-391 Pharmacokinetic Study Phase I
December 22, 2016 updated by: Chong Kun Dang Pharmaceutical
Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
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
19 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Bwt >=50kg, BMI 18.5~25
- signed the informed consent form prior to the study participation
Exclusion Criteria:
- - Clinically significant disease
- Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- Clinically significant allergic disease
- Impossible to taking the institutional standard meal
- Previously donate whole blood within 60 days or component blood within 20 days
- Previously participated in other trial within 90 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
|
Investigational products are prescribed to all of radomized subjects for two times.
Investigational product is prescribed to all of randomized subjects for two times.
|
Experimental: RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
|
Investigational products are prescribed to all of radomized subjects for two times.
Investigational product is prescribed to all of randomized subjects for two times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast
Time Frame: up to 96 hours post dose
|
up to 96 hours post dose
|
Cmax
Time Frame: up to 96 hours post dose
|
up to 96 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax
Time Frame: up to 96 hours post dose
|
up to 96 hours post dose
|
T1/2
Time Frame: up to 96 hours post dose
|
up to 96 hours post dose
|
AUCinf
Time Frame: up to 96 hours post dose
|
up to 96 hours post dose
|
Adverse events
Time Frame: up to 24days post dose
|
up to 24days post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Choon Ok Kim, Ph.D, Severance 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
August 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 16, 2015
First Submitted That Met QC Criteria
July 16, 2015
First Posted (Estimate)
July 17, 2015
Study Record Updates
Last Update Posted (Estimate)
December 26, 2016
Last Update Submitted That Met QC Criteria
December 22, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 152BE15026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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