NCT05181124

Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian

Clinical Trial To Evaluate Pharmacokinetic Interactions and Safety Between JP-1366 and Aceclofenac, Meloxicam, and Naproxen in Korean Healthy Volunteers and Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Onconic Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of coadministration of aceclofenac, meloxicam and naproxen on pharmacokinetic interactions and safety of JP-1366 in healthy Korean subjects and to compare the pharmacokinetic nature and safety of JP-1366 between healthy Korean and Caucasian.

Conditions

• Anti-Ulcer Agents

Interventions

Type	Name	Description
DRUG	coadministration of JP-1366 and aceclofenac	An open-label, multiple-dosing, fixed sequence, 3-period design
DRUG	coadministration of JP-1366 and meloxicam	An open-label, multiple-dosing, fixed sequence, 3-period design
DRUG	coadministration of JP-1366 and naproxen	An open-label, multiple-dosing, fixed sequence, 3-period design
DRUG	single-dosing of JP-1366 in Korean and Caucasian	An open-label, single-dosing, parallel design

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-03-15
• Completion: 2021-03-23
• First posted: 2022-01-06
• Last updated: 2022-06-30

Locations

1 site across 1 country: South Korea