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Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

NCT ID: NCT05712681

Last Updated: 2024-08-26

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2023-05-18

Brief Summary

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To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

T → Washout period(7-14days) → R

Group Type EXPERIMENTAL

JP-1366 20mg tablet

Intervention Type DRUG

T : JP-1366 20mg tablet after the meal

JP-1366 20mg tablet

Intervention Type DRUG

R : JP-1366 20mg tablet under fasting condition

Sequence 2

R → Washout period(7-14days) → T

Group Type EXPERIMENTAL

JP-1366 20mg tablet

Intervention Type DRUG

T : JP-1366 20mg tablet after the meal

JP-1366 20mg tablet

Intervention Type DRUG

R : JP-1366 20mg tablet under fasting condition

Interventions

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JP-1366 20mg tablet

T : JP-1366 20mg tablet after the meal

Intervention Type DRUG

JP-1366 20mg tablet

R : JP-1366 20mg tablet under fasting condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A healthy adult aged between 19 and 45 years old
* BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening

Exclusion Criteria

* The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
* The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
* The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
* The subject who has other clinically significant diseases or history
* The subject who has a history of drug abuse
* The subject who cannot withstand the insertion and maintenance of pH catheters
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Onconic Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan Medical Central

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JP-1366-105

Identifier Type: -

Identifier Source: org_study_id

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