A Phase 1 Clinical Trial to Evaluate the Safety and Pharm... | NCT05214690

Studies
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

NCT05214690

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 31, 2022Actual

Enrollment

37Actual

Phase

Phase 1

Conditions

Osteoarthritis
Rheumatoid Arthritis
Back Pain
Acute Upper Respiratory Tract Infection

Interventions

DW1809-T2
DW1809-1

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2020Actual

Primary Completion Date

Sep 8, 2020Actual

Completion Date

Sep 8, 2020Actual

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

Jan 28, 2022

First Posted Date

Jan 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2022

Last Update Posted Date

Jan 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Experimental	cross-over	Drug: DW1809-T2 Drug: DW1809-1
Sequence B	Experimental	cross-over	Drug: DW1809-T2 Drug: DW1809-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DW1809-T2	Drug	pelubiprofen 25mg	Sequence A Sequence B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax)	Pharmacokinetics of Pelubiprofen	up to 8 hour
Area under the plasma concentration versus time curve (AUC)	Pharmacokinetics of Pelubiprofen	up to 8 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungbuk National University Hospital		Cheongju-si			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid
D001416	Back Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided