NCT06378684

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Detailed description

Pharmacokinetic Interactions: 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	Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
DRUG	Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
DRUG	Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
DRUG	Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
DRUG	Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
DRUG	Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)	Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Timeline

• Start date: 2023-09-10
• Primary completion: 2023-12-23
• Completion: 2024-01-13
• First posted: 2024-04-22
• Last updated: 2024-04-22

Locations

1 site across 1 country: South Korea