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| ID | Type | Description | Link |
|---|---|---|---|
| TSGHIRB097-02-006 | |||
| C159 |
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The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test drug | Experimental | Levetiracetam one period |
|
| Reference drug | Active Comparator | Keppra one period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) | Drug | Levetiracetam 500mg/tablet Oral once |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the bioequivalence | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I-Shin Shiah, M.D. | Tri-Service General Hospital (TSGH) | Principal Investigator |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Keppra (Levetiracetam - USB SA Pharma Sector) | Drug | Levetiracetam 500mg/tablet oral once |
|
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |