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The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.
This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fasting conditions with a washout period of 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited |
|
| Keppra® | Active Comparator | Keppra® 750 mg Tablets of UCB Pharma Inc., |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability based on Cmax and AUC parameters | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of:
Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
Subjects who have made a plasma donation within 7 days prior to the first dose.
Subjects who have participated in another clinical trial within 30 days prior to the first dose.
Subjects with hemoglobin less than 12.0 g/dL.
Subjects who have participated in another clinical trial within 30 days prior to the first dose.
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| Name | Affiliation | Role |
|---|---|---|
| Magdy L Shenouda, MD | MDS Pharma Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Neptune City | New Jersey | 07753 | United States |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |