To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

JW Pharmaceutical31 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LivaloVDRUG

Treatment A, Tablet, Oral, QD for 7 Days

ADRUG

Treatment B, Tablet, Oral, QD for 10 Days

LivaloVADRUG

Treatment C, Tablet, Oral, QD for 7 Days

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Center, Chungnam National University Hospital

Daejeon, South Korea

Outcomes

Primary Outcomes

The Pharmacokinetics(PK) parameters AUCss,τ

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

Time frame: 0~24 hours

The Pharmacokinetics(PK) parameters Css,max

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

Time frame: 0~24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.