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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period I | Experimental | Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7 |
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| Period II | Experimental | Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23 |
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| Period III | Experimental | Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LivaloV | Drug | Treatment A, Tablet, Oral, QD for 7 Days |
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| Measure | Description | Time Frame |
|---|---|---|
| The Pharmacokinetics(PK) parameters AUCss,Ï„ | AUCss,Ï„ 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hee Hong, PI | Clinical Trial Center, Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Chungnam National University Hospital | Daejeon | South Korea |
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open label, multiple dose, Fixed sequence, 3 Period design
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| A | Drug | Treatment B, Tablet, Oral, QD for 10 Days |
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| LivaloVA | Drug | Treatment C, Tablet, Oral, QD for 7 Days |
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