Pharmacokinetics and Safety Following Administration of D... | NCT05414591

Studies
Pharmacokinetics and Safety Following Administration of DWP16001

NCT05414591

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Jul 13, 2022Actual

Enrollment

38Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DWP16001 drug A
DWP16001 drug B

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

Jun 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

May 1, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Aug 1, 2021Actual

First Submitted Date

Jun 8, 2022

First Submission Date that Met QC Criteria

Jun 8, 2022

First Posted Date

Jun 10, 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

Jul 11, 2022

Last Update Posted Date

Jul 13, 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

Description Module

Brief Summary

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

Detailed Description

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence group A	Experimental	DWP16001 A mg 1T	Drug: DWP16001 drug A Drug: DWP16001 drug B
Sequence group B	Experimental	DWP16001 B mg 3T	Drug: DWP16001 drug A Drug: DWP16001 drug B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP16001 drug A	Drug	1 tablet, Oral, once daily single dose	Sequence group A Sequence group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC0_t of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
Cmax of DWP16001	Peak Plasma Concetration	0-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Tmax Tmax	Time at Cmax Tmax	0-72 hours
AUC of DWP16001	Area under the plasma concentration versus time curve	0-72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult volunteers aged ≥ 19 years at screening
Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion Criteria:

Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
Clinical laboratory test values are outside the accepted normal range at screening
Other exclusive inclusion criteria, as defined in the protocol

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
CHA Bundang Medical Center, CHA University		Seongnam-si	Gyeonggi-do	13496	South Korea