NCT06119958

Brief Summary

This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult 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
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_1

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
4 days until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 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

1 month

First QC Date

October 23, 2023

Last Update Submit

November 5, 2023

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of DWC202313 and DWC202314

    Up to 14 days

  • AUCt,ss of DWC202313 and DWC202314

    Up to 14 days

Secondary Outcomes (6)

  • Tmax,ss of DWC202313 and DWC202314

    Up to 14 days

  • Cmin,ss of DWC202313 and DWC202314

    Up to 14 days

  • t1/2 of DWC202313 and DWC202314

    Up to 14 days

  • CLss/F of DWC202313 and DWC202314

    Up to 14 days

  • Vdss/F of DWC202313 and DWC202314

    Up to 14 days

  • +1 more secondary outcomes

Study Arms (2)

DWC202313

EXPERIMENTAL

DWC202313

Drug: DWC202313

DWC202314

EXPERIMENTAL

DWC202314

Drug: DWC202314

Interventions

DWC202313DRUG

Experimental Drug 1

DWC202313
DWC202314DRUG

Experimental Drug 2

DWC202314

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Seung-Hyun Kang, MD, Ph D

CONTACT

070-4665-9490juspa@newyjh.com

Study Design

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

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 7, 2023

Study Start

October 27, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations

KR(1)