Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers
An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jan 2015
Typical duration for phase_1 healthy
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
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 1, 2016
February 1, 2016
2 months
February 17, 2015
February 27, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax,ss
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary Outcomes (4)
Cmin,ss
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Tmax
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
t1/2
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic Ratio
Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Study Arms (3)
DWC20141
EXPERIMENTALmultiple dose of DWC20141
DWC20142
EXPERIMENTALmultiple dose of DWC20142
DWC20141+DWC20142
EXPERIMENTALmultiple dose of DWC20141 and DWC20142
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male volunteers aged 19 to 45 years
- A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
- A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints
You may not qualify if:
- A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
- A subject who shows the following result in clinical laboratory test
- AST, ALT \> 1.25 times of the upper limit of normal range
- PR ≥ 210 msec
- QRS ≥ 120 msec
- QT ≥ 500 msec
- QTcF ≥ 500 msec
- Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inje University College of Medicine Busan Paik Hospital
Busan, Busanjin-gu, 614-735, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Eun-Young Kim, Professor
BUSAN PAIK HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
February 23, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
March 1, 2016
Record last verified: 2016-02