NCT06361277

Brief Summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

November 3, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

17 days

First QC Date

March 27, 2024

Last Update Submit

April 8, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

    Day1 0h ~ Day3 48h

  • Cmax

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

    Day1 0h ~ Day3 48h

Study Arms (2)

Group 1

OTHER

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Drug: Reference Drug or Test Drug

Group 2

OTHER

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Drug: Reference Drug or Test Drug

Interventions

Reference Drug or Test DrugDRUG

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Also known as: Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)
Group 1Group 2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • MinGul Kim

    Jeonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 11, 2024

Study Start

November 3, 2023

Primary Completion

November 20, 2023

Study Completion

November 27, 2023

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)