Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01131897

AA06179

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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:
1. alcoholism or drug abuse within the past 2 years;
2. 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.