To Evaluate the Effect of Food on the Safety and PK Chara... | NCT05797922

Studies
To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers

NCT05797922

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Unknown status

Last Update Posted

Apr 4, 2023Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

DWP16001

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2023Actual

Primary Completion Date

May 31, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 4, 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

Apr 3, 2023

Last Update Posted Date

Apr 4, 2023Actual

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

This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.

Detailed Description

The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.

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

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWP16001 to Group A	Experimental	Group A: Fasting in Period 1 / Fed in Period 2	Drug: DWP16001
DWP16001 to Group B	Experimental	Group B: Fed in Period 1 / Fasting in Period 2	Drug: DWP16001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP16001	Drug	DWP16001 0.3mg	DWP16001 to Group A DWP16001 to Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC0-t of DWP16001	AUC0-t of DWP16001	0 to 72 hours
Cmax of DWP16001	Cmax of DWP16001	0 to 72 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
A person who is 19 years of age or more at the time of screening.
Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria:

A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)

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

Name	Role	Phone	Extension	Email
Daewoong Pharmaceutical	Contact	080-550-8308		yoonhye@daewoong.co.kr

Overall Officials

Name	Affiliation	Role
Chungbuk National University Hospital	Chungbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungbuk National University Hospital	Recruiting	Taebuk			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C000729921	Enavogliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided