To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105

NCT ID: NCT06754943

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-17

Study Completion Date

2025-04-22

Brief Summary

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The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Treatment B: Administration alone of 1 tablet of JW0105

Group Type OTHER

Treatment A_Period 1

Intervention Type DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Treatment B_Period 2

Intervention Type DRUG

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Treatment A_Period 3

Intervention Type DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Treatment B_Period 4

Intervention Type DRUG

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Group 2

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Treatment B: Administration alone of 1 tablet of JW0105

Group Type OTHER

Treatment B_Period 1

Intervention Type DRUG

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Treatment A_Period 2

Intervention Type DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Treatment B_Period 3

Intervention Type DRUG

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Treatment A_Period 4

Intervention Type DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Interventions

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Treatment A_Period 1

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment B_Period 2

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment A_Period 3

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment B_Period 4

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment B_Period 1

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment A_Period 2

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment B_Period 3

* Administration alone of 1 tablet of JW0105
* Wash-out period: 21 days
* Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Treatment A_Period 4

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Wash-out period: 21 days
* Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Intervention Type DRUG

Other Intervention Names

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NA (Not Applicable) NA (Not Applicable) NA (Not Applicable) NA (Not Applicable) NA (Not Applicable) NA (Not Applicable) NA (Not Applicable) NA (Not Applicable)

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung-Dae Kwon

Role: PRINCIPAL_INVESTIGATOR

Metro Hospital

Locations

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Metro Hospital

Anyang-si, Gyeonni-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JW24102

Identifier Type: -

Identifier Source: org_study_id

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