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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT06816719
• Lead Sponsor: JW Pharmaceutical

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-09-02
• Primary Completion: 2024-11-02
• Study Completion: 2024-11-12
• Study First Submitted: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Healthy volunteers

Exclusion Criteria

Subjects does not meet the inclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUCt	Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)	Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Cmax	Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)	Describes the blood concentration statistically by pharmacokinetic blood

Trial Locations

Locations (1)

Clinical Trial Center, Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Korea, Republic of