NCT06355349

Brief Summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 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
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2023

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

April 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 29, 2024

Last Update Submit

April 4, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

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

    Day1 0h ~ Day4 72h

  • Cmax

    Describes the blood concentration statistically by pharmacokinetic blood

    Day1 0h ~ Day4 72h

Study Arms (2)

Sequence A

OTHER

Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Drug: Reference Drug or Test Drug

Sequence B

OTHER

Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 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 21 days after administration

Also known as: Reference Drug(JW0101 and C2101) or Test Drug(JW0102)
Sequence ASequence B

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

  • SeolJu Moon

    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 29, 2024

First Posted

April 9, 2024

Study Start

April 28, 2023

Primary Completion

July 10, 2023

Study Completion

July 17, 2023

Last Updated

April 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)