NCT05797922

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 21, 2023

Last Update Submit

April 3, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC0-t of DWP16001

    AUC0-t of DWP16001

    0 to 72 hours

  • Cmax of DWP16001

    Cmax of DWP16001

    0 to 72 hours

Study Arms (2)

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

DWP16001DRUG

DWP16001 0.3mg

Also known as: DWP16001 0.3mg
DWP16001 to Group ADWP16001 to Group B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Jungbuk, South Korea

RECRUITING

MeSH Terms

Interventions

Enavogliflozin

Study Officials

  • Chungbuk National University Hospital

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daewoong Pharmaceutical

CONTACT

080-550-8308yoonhye@daewoong.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 4, 2023

Study Start

March 9, 2023

Primary Completion

May 31, 2023

Study Completion

November 30, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

KR(1)