CKD-391 Pharmacokinetic Study
Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
1 other identifier
interventional
52
1 country
1
Brief Summary
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 17, 2016
January 1, 2016
3 months
June 1, 2015
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUClast
up to 96 hours post dose
Cmax
up to 96 hours post dose
Secondary Outcomes (4)
Tmax
up to 96 hours post dose
T1/2
up to 96 hours post dose
AUCinf
up to 96 hours post dose
Adverse events
up to 24days post dose
Study Arms (2)
TR group
EXPERIMENTALCKD-391 and combination dose of Atrovastatin and Ezetimibe in order
RT group
EXPERIMENTALcombination dose of Atrovastatin and Ezetimibe and CKD-391 in order
Interventions
Investigational product is prescribed to all of radomized subjects for two times.
Investigational products are prescribed to all of radomized subjects for two times.
Eligibility Criteria
You may qualify if:
- Bwt \>=50kg, BMI 18\~29
- signed the informed consent form prior to the study participation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Young Park, Ph.D.
The Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 17, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share