- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06119958
Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects
November 5, 2023 updated by: Daewoong Pharmaceutical Co. LTD.
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Seung-Hyun Kang, MD, Ph D
- Phone Number: 070-4665-9490
- Email: juspa@newyjh.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- H plus Yangji Hospital
-
Contact:
- Seung-Hyun Kang, MD, Ph D.
- Phone Number: 070-4665-9490
- Email: juspa@newyjh.com
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- over 19 year old
Exclusion Criteria:
- Galactose intolerance
- Lapp lactase deficiency
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DWC202313
|
Experimental Drug 1
|
Experimental: DWC202314
|
Experimental Drug 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
AUCt,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
Cmin,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
t1/2 of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
CLss/F of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
Vdss/F of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
PTF of DWC202313 and DWC202314
Time Frame: Up to 14 days
|
Up to 14 days
|
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)
October 27, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
November 5, 2023
First Posted (Actual)
November 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- DWJ1622101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Drug Drug Interaction
-
Hutchison Medipharma LimitedCompletedFood-drug Interaction | Drug InteractionUnited States
-
University of Southern CaliforniaRecruitingDrug Drug InteractionUnited States
-
Daewoong Pharmaceutical Co. LTD.Active, not recruitingDrug Drug InteractionKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.Enrolling by invitationDrug-drug InteractionKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.CompletedDrug Drug InteractionKorea, Republic of
-
ItalfarmacoCompletedDrug-Drug InteractionPortugal
-
Aurinia Pharmaceuticals Inc.CompletedDrug-drug InteractionUnited States
-
Blade TherapeuticsCompletedDrug Drug InteractionUnited States
-
Daewoong Pharmaceutical Co. LTD.CompletedDrug-drug InteractionAustralia
-
Nanjing Yoko Biomedical Co., Ltd.CompletedDrug-drug InteractionChina