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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Anti-Ulcer Agents

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JP-1366 and aceclofenac

Group Type EXPERIMENTAL

coadministration of JP-1366 and aceclofenac

Intervention Type DRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

JP-1366 and meloxicam

Group Type EXPERIMENTAL

coadministration of JP-1366 and meloxicam

Intervention Type DRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

JP-1366 and naproxen

Group Type EXPERIMENTAL

coadministration of JP-1366 and naproxen

Intervention Type DRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

JP-1366

Group Type EXPERIMENTAL

single-dosing of JP-1366 in Korean and Caucasian

Intervention Type DRUG

An open-label, single-dosing, parallel design

Interventions

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coadministration of JP-1366 and aceclofenac

An open-label, multiple-dosing, fixed sequence, 3-period design

Intervention Type DRUG

coadministration of JP-1366 and meloxicam

An open-label, multiple-dosing, fixed sequence, 3-period design

Intervention Type DRUG

coadministration of JP-1366 and naproxen

An open-label, multiple-dosing, fixed sequence, 3-period design

Intervention Type DRUG

single-dosing of JP-1366 in Korean and Caucasian

An open-label, single-dosing, parallel design

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes