To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

NCT ID: NCT05351840

Last Updated: 2022-08-12

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-01-15

Brief Summary

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To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination

Detailed Description

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The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

open label, multiple dose, Fixed sequence, 3 Period design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Period I

Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7

Group Type EXPERIMENTAL

LivaloV

Intervention Type DRUG

Treatment A, Tablet, Oral, QD for 7 Days

Period II

Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23

Group Type EXPERIMENTAL

A

Intervention Type DRUG

Treatment B, Tablet, Oral, QD for 10 Days

Period III

Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30

Group Type EXPERIMENTAL

LivaloVA

Intervention Type DRUG

Treatment C, Tablet, Oral, QD for 7 Days

Interventions

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LivaloV

Treatment A, Tablet, Oral, QD for 7 Days

Intervention Type DRUG

A

Treatment B, Tablet, Oral, QD for 10 Days

Intervention Type DRUG

LivaloVA

Treatment C, Tablet, Oral, QD for 7 Days

Intervention Type DRUG

Other Intervention Names

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Period I Period II Period III

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.
* Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent

Exclusion Criteria

* Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.
* Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jang Hee Hong, PI

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Chungnam National University Hospital

Locations

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Clinical Trial Center, Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JWP-PVA-101

Identifier Type: -

Identifier Source: org_study_id

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