To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: A; Drug: LivaloVA; Drug: LivaloV

• Registration Number: NCT05351840
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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

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 Timeline

• Study Start: 2020-11-02
• Primary Completion: 2020-12-19
• Study Completion: 2021-01-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Period II	A	Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23
Period III	LivaloVA	Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30
Period I	LivaloV	Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7

Primary Outcome Measures

Name	Time	Method
The Pharmacokinetics(PK) parameters AUCss,τ	0~24 hours	AUCss,τ in a steady-state after multiple-dose (single or combined administration).
The Pharmacokinetics(PK) parameters Css,max	0~24 hours	Css,max in a steady-state after multiple-dose (single or combined administration).

Trial Locations

Locations (1)

Clinical Trial Center, Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of