Back to resultsA Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Back Pain
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DW1809-T2
DW1809-1
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Healthy Volunteers who are ≥19 years old
- Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Exclusion Criteria:
- Clinically significant Medical History
- In the case of women, pregnant(Urine-HCG positive) or lactating women
Sites / Locations
- Chungbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
cross-over
cross-over
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Pharmacokinetics of Pelubiprofen
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of Pelubiprofen
Secondary Outcome Measures
Full Information
NCT ID
NCT05214690
First Posted
December 12, 2021
Last Updated
January 28, 2022
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05214690
Brief Title
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2
Official Title
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
September 8, 2020 (Actual)
Study Completion Date
September 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Back Pain, Acute Upper Respiratory Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
cross-over
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
cross-over
Intervention Type
Drug
Intervention Name(s)
DW1809-T2
Other Intervention Name(s)
Test
Intervention Description
pelubiprofen 25mg
Intervention Type
Drug
Intervention Name(s)
DW1809-1
Other Intervention Name(s)
Reference
Intervention Description
pelubiprofen 30mg (PELUBI tab.)
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Pharmacokinetics of Pelubiprofen
Time Frame
up to 8 hour
Title
Area under the plasma concentration versus time curve (AUC)
Description
Pharmacokinetics of Pelubiprofen
Time Frame
up to 8 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers who are ≥19 years old
Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Exclusion Criteria:
Clinically significant Medical History
In the case of women, pregnant(Urine-HCG positive) or lactating women
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2
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