Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects
Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06119958
Collaborator
(none)
32
1
2
1.1
27.8
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Oct 27, 2023
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DWC202313 DWC202313 |
Drug: DWC202313
Experimental Drug 1
|
| Experimental: DWC202314 DWC202314 |
Drug: DWC202314
Experimental Drug 2
|
Outcome Measures
Primary Outcome Measures
- Cmax,ss of DWC202313 and DWC202314 [Up to 14 days]
- AUCt,ss of DWC202313 and DWC202314 [Up to 14 days]
Secondary Outcome Measures
- Tmax,ss of DWC202313 and DWC202314 [Up to 14 days]
- Cmin,ss of DWC202313 and DWC202314 [Up to 14 days]
- t1/2 of DWC202313 and DWC202314 [Up to 14 days]
- CLss/F of DWC202313 and DWC202314 [Up to 14 days]
- Vdss/F of DWC202313 and DWC202314 [Up to 14 days]
- PTF of DWC202313 and DWC202314 [Up to 14 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- over 19 year old
Exclusion Criteria:
-
Galactose intolerance
-
Lapp lactase deficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H Plus YANGJI Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT06119958
Other Study ID Numbers:
- DWJ1622101
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No