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OpenTrials
Completed

NCT Number: NCT05351840

To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Chungnam National University Hospital

Daejeon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LivaloV

Drug

Treatment A, Tablet, Oral, QD for 7 Days

Other names: Period I

A

Drug

Treatment B, Tablet, Oral, QD for 10 Days

Other names: Period II

LivaloVA

Drug

Treatment C, Tablet, Oral, QD for 7 Days

Other names: Period III

Primary outcomes

  1. The Pharmacokinetics(PK) parameters AUCss,τ

    Time frame: 0~24 hours

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

  2. The Pharmacokinetics(PK) parameters Css,max

    Time frame: 0~24 hours

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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 28, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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