Anti-Ulcer Agents
Conditions
Brief 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.
Interventions
DRUGcoadministration of JP-1366 and aceclofenac
An open-label, multiple-dosing, fixed sequence, 3-period design
DRUGcoadministration of JP-1366 and meloxicam
An open-label, multiple-dosing, fixed sequence, 3-period design
DRUGcoadministration of JP-1366 and naproxen
An open-label, multiple-dosing, fixed sequence, 3-period design
DRUGsingle-dosing of JP-1366 in Korean and Caucasian
An open-label, single-dosing, parallel design
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject who has fully informed about this study and understand co mpletely, decide to participate voluntarily and agree with the writte n consent before screening test. * A healthy volunteer in the age of upper 19 at the time of the scree ning test. * Subject whose BMI was 18.0 or more and 30.0 or less and whose b ody weight was 50kg or more if in male, and 45kg or more if in fe male at the same time. * Caucasian in Part 4 who has medical interview and documents(passport, birth certificate) or signatured conformation by the subject.
Exclusion criteria
* The Subject who has clinically significant diseases with liver, kidney, nervous system, digestive system, immune system, respiratory system, and endocrine system, musculoskeletal system or the blood or tumor disease, cardiovascular disease (including orthostatic hypotension), mental disorder or with history of the disease. * The subject who has a history of gastrointestinal disorders (gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc.) or history of gastrointestinal surgery that may affect the safety and PK/PD Evaluation of the investigational product (Except for simple cecal surgery and hernia surgery) * The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.). * The subject who has a history of an active peptic ulcer or bleeding. * Screening laboratory test showing any of the following abnormal laboratory results: ALT, AST, Total bilirubin \> 2.0 x ULN - e-GFR \< 60 mL/min/1.73m2 (CKD-EPI formula) - Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis regain test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 | Single dosing of aceclofenac: 1day 0hour (before IP administration), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hour | \- Cmax,ss of JP-1366 |
| Part 2 | Single dosing of JP-1366: 1day 0hour, 3day 0hour, 4day 0hour, 5day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (6day 0hour), 15day 0hour (before IP administration) | \- Cmax,ss of JP-1366, meloxicam |
| Part 3 | Single dosing of JP-1366: 1day 0hour, 3day 0hour, 4day 0hour, 5day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (6day 0hour), 15day 0hour (before IP administration) | \- Cmax,ss of JP-1366, naproxen |
| Part 4 | 1day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 (2day 0hour), 48hour (3day 0hour) | \- Cmax of JP-1366 in Korean and Caucasian |
Countries
South Korea
Outcome results
None listed