Bioequivalence Study for the Safety and the Pharmacokinet... | NCT05954247

Studies
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

NCT05954247

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

DWJ1543
DWC202216

Countries

Not provided

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Estimated

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 12, 2023

First Posted Date

Jul 20, 2023Actual

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

Jul 21, 2023

Last Update Posted Date

Jul 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention: DWJ1543	Experimental		Drug: DWJ1543
Intervention: DWC202216	Experimental		Drug: DWC202216

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWJ1543	Drug	DWJ1543	Intervention: DWJ1543
DWC202216

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543		At pre-dose (0 hour), and post-dose 1 to 120 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543		At pre-dose (0 hour), and post-dose 1 to 120 hour.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 19 year old
Healthy adult volunteers

Exclusion Criteria:

Eye disorders including cataracts
Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Accepts Healthy Volunteers

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