NCT05433844

To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Detailed description

1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation. To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement. 2. All subjects who received more than one dose of clinical trial drugs are evaluated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference Drug or Test Drug	Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Timeline

• Start date: 2022-06-02
• Primary completion: 2022-08-26
• Completion: 2022-09-14
• First posted: 2022-06-27
• Last updated: 2024-03-21

Locations

1 site across 1 country: South Korea