NCT06119945

Brief Summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

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
44

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

October 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

22 days

First QC Date

October 23, 2023

Last Update Submit

November 5, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

  • AUCt of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

Secondary Outcomes (4)

  • AUCinf of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

  • Tmax of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

  • AUCt/AUCinf of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

  • t1/2 of DWJ1568 and DWC202215

    At pre-dose (0 hour), and post-dose 0 to 72 hour.

Study Arms (2)

DWJ1568

EXPERIMENTAL

DWJ1568

Drug: DWJ1568

DWC202215

ACTIVE COMPARATOR

DWC202215

Drug: DWC202215

Interventions

DWJ1568DRUG

One tablet of DWJ1568

DWJ1568
DWC202215DRUG

One tablet of DWC202215

DWC202215

Eligibility Criteria

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

You may qualify if:

  • over 19 year old

You may not qualify if:

  • Galactose intolerance
  • Lapp lactase deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus YANGJI Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

MunJung Bae, MD, Ph D

CONTACT

070-4665-9174m4222@newyjh.com

Study Design

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

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 7, 2023

Study Start

November 9, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations

KR(1)