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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05351840

Enrollment

Registered

2022-04-28

Start date

2020-11-02

Completion date

2021-01-15

Last updated

2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLivaloV

Treatment A, Tablet, Oral, QD for 7 Days

DRUGA

Treatment B, Tablet, Oral, QD for 10 Days

DRUGLivaloVA

Treatment C, Tablet, Oral, QD for 7 Days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Intervention model description

open label, multiple dose, Fixed sequence, 3 Period design

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026