To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107

NCT ID: NCT06816719

Last Updated: 2025-02-10

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2024-11-12

Brief Summary

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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.

Detailed Description

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

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1

(Period 1/3: Treatment A) (Period 2/4: Treatment B)

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

Group Type OTHER

Treatment A: JW0106 1 tablet + C2101 1 tablet

Intervention Type DRUG

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

Treatment B: JW0107 1 tablet

Intervention Type DRUG

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

Sequence 2

(Period 1/3: Treatment B) (Period 2/4: Treatment A)

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

Group Type OTHER

Treatment A: JW0106 1 tablet + C2101 1 tablet

Intervention Type DRUG

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

Treatment B: JW0107 1 tablet

Intervention Type DRUG

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

Interventions

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Treatment A: JW0106 1 tablet + C2101 1 tablet

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

Intervention Type DRUG

Treatment B: JW0107 1 tablet

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

Intervention Type DRUG

Other Intervention Names

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Administration alone of 1 tablet of JW0107

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

Locations

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Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, Korea, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JW24107

Identifier Type: -

Identifier Source: org_study_id

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