NCT05463497

To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Detailed description

1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults. 2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A	JW0201: single administration, Tablet, Oral, BID for 5 days
DRUG	Treatment B	C2103: single administration, Tablet, Oral, BID for 5 days
DRUG	Treatment C	JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
DRUG	Treatment D	C2104 : single administration, Tablet, Oral, QD for 5 days
DRUG	Treatment E	JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-03-16
• Completion: 2022-03-23
• First posted: 2022-07-19
• Last updated: 2022-07-19

Locations

1 site across 1 country: South Korea