To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

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

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LivaloV
* Drug: A
* Drug: LivaloVA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: open label, multiple dose, Fixed sequence, 3 Period design
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |