to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2026-03-30

Brief Summary

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to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban

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Detailed Description

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Conditions

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Drug Drug Interaction (DDI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (open label)

Study Groups

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Part 1

JP-1366 and clopidogrel

Group Type EXPERIMENTAL

JP-1366 and clopidogrel

Intervention Type DRUG

A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design

Part 2

JP-1366 and aspirin

Group Type EXPERIMENTAL

JP-1366 and aspirin

Intervention Type DRUG

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

Part 3

JP-1366 and atorvastatin

Group Type EXPERIMENTAL

JP-1366 and atorvastatin

Intervention Type DRUG

An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin

Part 4

JP-1366 and apixaban

Group Type EXPERIMENTAL

JP-1366 and apixaban

Intervention Type DRUG

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

Interventions

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JP-1366 and clopidogrel

A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design

Intervention Type DRUG

JP-1366 and aspirin

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

Intervention Type DRUG

JP-1366 and atorvastatin

An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin

Intervention Type DRUG

JP-1366 and apixaban

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subject aged ≥ 19 years to \< 65 years at the time of screening
* Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
* Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.

Exclusion Criteria

* Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.
* The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
* Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.
* The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
* Screening laboratory test showing any of the following abnormal laboratory results
* Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes