Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
Completed · Phase 1
Conditions studied: Healthy
In brief
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 fed conditions.
Key facts
- Study ID
- NCT01132352
- Run by
- Dr. Reddy's Laboratories Limited
- People needed
- 24
- Starts
- 2003-09-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2010-06-14
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy adult male volunteers, 18 to 55 years of age;
- Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
- Voluntarily consent to participate in the study
You may not qualify if…
- History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past 2 years;
- hypersensitivity or idiosyncratic reaction to levetiracetam;
- 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.
Where it is running
- MDS Pharma Services — Neptune City, New Jersey, United States
Full record on ClinicalTrials.gov
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