Back to resultsA Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
Primary Purpose
Dyslipidemias, Hypertension
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring dyslipidemias, hypertension, Drug-Drug interaction
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers aged between ≥ 19 and ≤ 40 years old
- Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
- Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
- Subject who agree not to provide sperm
- Subject who voluntarily agree to participate in this study
Exclusion Criteria:
- Any medical history that may affect drug absorption, distribution, metabolism and excretion
- Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who have received other clinical trial drugs within 90 days prior to the screening visit
- Any clinically significant active chronic disease
Sites / Locations
- Asan Medical Center, University of UlsanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Arm Description
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Outcomes
Primary Outcome Measures
Cmax(Maximum plasma concentration of the drug at steady state)
PK parameters of D326, D337 and CKD-828
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
PK parameters of D326, D337 and CKD-828
Secondary Outcome Measures
Tmax(Time to maximum plasma concentration at steady state)
PK parameters of D326, D337 and CKD-828
t1/2(Terminal elimination half-life)
PK parameters of D326, D337 and CKD-828
Full Information
NCT ID
NCT03726866
First Posted
October 30, 2018
Last Updated
October 30, 2018
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03726866
Brief Title
A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
Official Title
A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Anticipated)
Study Completion Date
January 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
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 evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Hypertension
Keywords
dyslipidemias, hypertension, Drug-Drug interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Sequence 1
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Sequence 2
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Sequence 3
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Sequence 4
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Sequence 5
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Sequence 6
Intervention Type
Drug
Intervention Name(s)
Sequence 1
Intervention Description
D326, D337 or CKD-828 for 9 days
Intervention Type
Drug
Intervention Name(s)
Sequence 2
Intervention Description
D326, D337 or CKD-828 for 9 days
Intervention Type
Drug
Intervention Name(s)
Sequence 3
Intervention Description
D326, D337 or CKD-828 for 9 days
Intervention Type
Drug
Intervention Name(s)
Sequence 4
Intervention Description
D326, D337 or CKD-828 for 9 days
Intervention Type
Drug
Intervention Name(s)
Sequence 5
Intervention Description
D326, D337 or CKD-828 for 9 days
Intervention Type
Drug
Intervention Name(s)
Sequence 6
Intervention Description
D326, D337 or CKD-828 for 9 days
Primary Outcome Measure Information:
Title
Cmax(Maximum plasma concentration of the drug at steady state)
Description
PK parameters of D326, D337 and CKD-828
Time Frame
at Day 9
Title
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
Description
PK parameters of D326, D337 and CKD-828
Time Frame
at Day 9
Secondary Outcome Measure Information:
Title
Tmax(Time to maximum plasma concentration at steady state)
Description
PK parameters of D326, D337 and CKD-828
Time Frame
at Day 9
Title
t1/2(Terminal elimination half-life)
Description
PK parameters of D326, D337 and CKD-828
Time Frame
at Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers aged between ≥ 19 and ≤ 40 years old
Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
Subject who agree not to provide sperm
Subject who voluntarily agree to participate in this study
Exclusion Criteria:
Any medical history that may affect drug absorption, distribution, metabolism and excretion
Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
Subject who have received other clinical trial drugs within 90 days prior to the screening visit
Any clinically significant active chronic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihwan Oh
Phone
82-2-6373-0953
Email
jihwan@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong-Seok Lim, M.D., Ph.D.
Organizational Affiliation
Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
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