Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian
Phase 1
Completed
- Conditions
- Anti-Ulcer Agents
- Interventions
- Drug: coadministration of JP-1366 and aceclofenacDrug: coadministration of JP-1366 and meloxicamDrug: coadministration of JP-1366 and naproxenDrug: single-dosing of JP-1366 in Korean and Caucasian
- Registration Number
- NCT05181124
- Lead Sponsor
- Onconic Therapeutics Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description JP-1366 and aceclofenac coadministration of JP-1366 and aceclofenac - JP-1366 and meloxicam coadministration of JP-1366 and meloxicam - JP-1366 and naproxen coadministration of JP-1366 and naproxen - JP-1366 single-dosing of JP-1366 in Korean and Caucasian -
- Primary Outcome Measures
Name Time Method Part 1 Coadministration of JP-1366 and aceclofenac: 9day 0hour (before IP administration), 0.25, 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 6, 8, 10, 12, 24hour (10day 0hour) - AUCτ of aceclofenac
Part 3 Coadministration of JP-1366 and naproxen: 22day 0hour† , 24day 0hour† , 25day 0hour† , 26day 0hour (before IP administration), 0.25† , 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 5, 6, 8, 10† , 12, 24hour (27day 0hour) - AUCτ,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) - AUClast of JP-1366 in Korean and Caucasian
Part 2 Coadministration of JP-1366 and meloxicam: 22day 0hour† , 24day 0hour† , 25day 0hour† , 26day 0hour (before IP administration), 0.25† , 0.5† , 0.75† , 1, 1.5† , 2, 3, 4, 5‡ , 6, 8, 10† , 12, 24hour (27day 0hour) - AUCτ,ss of JP-1366, meloxicam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cha University Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of