- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03005223
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers
February 14, 2017 updated by: Daewoong Pharmaceutical Co. LTD.
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
52
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:
- Accepts healthy volunteers
Exclusion Criteria:
- Who has allergy to investigational product
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: Study effect of DWC20163 on DWC20155/DWC20156 PK
To study effect of DWC20163 on DWC20155/DWC20156 PK
|
|
Experimental: Study effect of DWC20155/DWC20156 on DWC20163 PK
To study effect of DWC20155/DWC20156 on DWC20163 PK
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: 0 ~ 24 hours
|
0 ~ 24 hours
|
Area under the time versus plasma concentration curve (AUC)
Time Frame: 0 ~ 24 hours
|
0 ~ 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 4, 2017
Primary Completion (Anticipated)
May 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
December 26, 2016
First Submitted That Met QC Criteria
December 26, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
February 16, 2017
Last Update Submitted That Met QC Criteria
February 14, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- DW_DWJ1366005
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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