To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study 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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LivaloV; Drug: A; Drug: LivaloVA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Clinical Trial Center, Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Period I; Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7	Drug: LivaloV; Treatment A, Tablet, Oral, QD for 7 Days; Other Names: Period I
EXPERIMENTAL: Period II; Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23	Drug: A; Treatment B, Tablet, Oral, QD for 10 Days; Other Names: Period II
EXPERIMENTAL: Period III; Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30	Drug: LivaloVA; Treatment C, Tablet, Oral, QD for 7 Days; Other Names: Period III

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Jang Hee Hong, PI, Clinical Trial Center, Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2020
• Primary Completion (ACTUAL): December 19, 2020
• Study Completion (ACTUAL): January 15, 2021

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (ACTUAL): April 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JWP-PVA-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No