An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- The Pharmacokinetics(PK) parameters AUCss,τ
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Period II
Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23
Intervention: A (Drug)
Period III
Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30
Intervention: LivaloVA (Drug)
Period I
Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7
Intervention: LivaloV (Drug)
Outcomes
Primary Outcomes
The Pharmacokinetics(PK) parameters AUCss,τ
Time Frame: 0~24 hours
AUCss,τ in a steady-state after multiple-dose (single or combined administration).
The Pharmacokinetics(PK) parameters Css,max
Time Frame: 0~24 hours
Css,max in a steady-state after multiple-dose (single or combined administration).
Secondary Outcomes
No secondary outcomes reported