NCT06816719

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

A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0106 and C2101 and Administration of JW0107 in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	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
DRUG	Treatment B: JW0107 1 tablet	* Administration alone of 1 tablet of JW0107 * Administration orally with 150 mL of water under fasting conditions

Timeline

• Start date: 2024-09-02
• Primary completion: 2024-11-02
• Completion: 2024-11-12
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: South Korea