NCT06816719

Brief Summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 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
47

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2024

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

September 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

January 1, 2025

Last Update Submit

February 7, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

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

    Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)

  • Cmax

    Describes the blood concentration statistically by pharmacokinetic blood

    Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)

Study Arms (2)

Sequence 1

OTHER

(Period 1/3: Treatment A) (Period 2/4: Treatment B) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

Drug: Treatment A: JW0106 1 tablet + C2101 1 tabletDrug: Treatment B: JW0107 1 tablet

Sequence 2

OTHER

(Period 1/3: Treatment B) (Period 2/4: Treatment A) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

Drug: Treatment A: JW0106 1 tablet + C2101 1 tabletDrug: Treatment B: JW0107 1 tablet

Interventions

Treatment A: JW0106 1 tablet + C2101 1 tabletDRUG

* Co-administration of 1 tablet of JW0106 and 1 tablet of C2101 * Administration orally with 150 mL of water under fasting conditions

Sequence 1Sequence 2
Treatment B: JW0107 1 tabletDRUG

* Administration alone of 1 tablet of JW0107 * Administration orally with 150 mL of water under fasting conditions

Also known as: Administration alone of 1 tablet of JW0107
Sequence 1Sequence 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, Korea, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

January 1, 2025

First Posted

February 10, 2025

Study Start

September 2, 2024

Primary Completion

November 2, 2024

Study Completion

November 12, 2024

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations

KR(1)