NCT05784155

To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test Drug(JW0302) or Reference Drug(C2206)	Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Timeline

• Start date: 2023-03-10
• Primary completion: 2023-06-09
• Completion: 2023-06-26
• First posted: 2023-03-24
• Last updated: 2024-03-20

Locations

1 site across 1 country: South Korea