Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT04328766
Collaborator
(none)
36
1
3
2.5
14.4
Study Details
Study Description
Brief Summary
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Actual Study Start Date
:
Sep 6, 2020
Actual Primary Completion Date
:
Nov 21, 2020
Actual Study Completion Date
:
Nov 21, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DWP14012 Cohort A
|
Drug: DWC202005, alone
DWC202005, as a single dose
|
| Experimental: DWP14012 Cohort B
|
Drug: DWP14012 + DWC202005
DWP14012 and DWC202005, as a single dose
|
| Experimental: DWP14012 Cohort C
|
Drug: DWP14012 + DWC202005, after multiple doses of DWP14012
DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days
|
Outcome Measures
Primary Outcome Measures
- Area under the plasma drug concentration-time curve [upto 48 hours postdose]
AUClast of DWC202005
- Peak Plasma Concentration (Cmax) [upto 48 hours postdose]
Cmax of DWC202005
- Incidence of Treatment-Emergent Adverse Events [up to 19 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
-
Capable of understanding provided information and complying with protocol requirements
-
Provide written informed consent to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nucleus Network (QPharm) | Queensland | Australia | 78 |
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:
NCT04328766
Other Study ID Numbers:
- DW_DWP14012106
First Posted:
Mar 31, 2020
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No