Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

This study has been completed.

First Received on September 19, 2007. Last Updated on January 31, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601575

Purpose

The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Condition	Intervention
Bipolar Disorder	Drug: Lithium

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Malnutrition

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Three period, Fourteen day washout ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	October 2002
Study Completion Date:	November 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Participation in a clinicl trial within 30 days prior to study initiation.
Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601575

Locations

United States, Arkansas
Arkansas Research
Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Jerry Herron, MD

Arkansas Research

More Information

No publications provided

Responsible Party:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00601575 History of Changes
Other Study ID Numbers:	LITH-09
Study First Received:	September 19, 2007
Last Updated:	January 31, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium Carbonate
Lithium
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 12, 2012