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

NCT05181124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-06-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Onconic Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-03-15
Completion
2021-03-23

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181124 on ClinicalTrials.gov