NCT05351840

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

August 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 14, 2022

Last Update Submit

August 9, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • The Pharmacokinetics(PK) parameters AUCss,τ

    AUCss,τ in a steady-state after multiple-dose (single or combined administration).

    0~24 hours

  • The Pharmacokinetics(PK) parameters Css,max

    Css,max in a steady-state after multiple-dose (single or combined administration).

    0~24 hours

Study Arms (3)

Period I

EXPERIMENTAL

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

Drug: LivaloV

Period II

EXPERIMENTAL

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

Drug: A

Period III

EXPERIMENTAL

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

Drug: LivaloVA

Interventions

LivaloVDRUG

Treatment A, Tablet, Oral, QD for 7 Days

Also known as: Period I
Period I
ADRUG

Treatment B, Tablet, Oral, QD for 10 Days

Also known as: Period II
Period II
LivaloVADRUG

Treatment C, Tablet, Oral, QD for 7 Days

Also known as: Period III
Period III

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Chungnam National University Hospital

Daejeon, South Korea

Location

Study Officials

  • Jang Hee Hong, PI

    Clinical Trial Center, Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: open label, multiple dose, Fixed sequence, 3 Period design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 28, 2022

Study Start

November 2, 2020

Primary Completion

December 19, 2020

Study Completion

January 15, 2021

Last Updated

August 12, 2022

Record last verified: 2022-04

Locations

KR(1)