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

NCT01131897 | Completed Phase 1 DMC

• 1 other identifier: AA06179
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioavailability; Crossover; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• Bioavailability based on Cmax and AUC parameters

  3 months

Study Arms (2)

Levetiracetam

EXPERIMENTAL

Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited

Drug: Levetiracetam

Keppra®

ACTIVE COMPARATOR

Keppra® 750 mg Tablets of UCB Pharma Inc.,

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited

Also known as: Keppra® 750 mg Tablets

Keppra®; Levetiracetam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

MDS Pharma Services

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Magdy L Shenouda, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: September 1, 2003
• Primary Completion: September 1, 2003
• Study Completion: November 1, 2003
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

US (1)