Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions - Full Text View

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 fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Condition	Intervention
Bipolar Disorder	Drug: Lithium

MedlinePlus related topics:

Bipolar Disorder

ChemIDplus related topics:

Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Official Title:	A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions

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:	November 2002
Study Completion Date:	November 2002
Primary Completion Date:	November 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: NCT00602381

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

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	LITH-08
First Received:	September 19, 2007
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00602381
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Mood Disorders

Lithium Carbonate

Psychotic Disorders

Lithium

Additional relevant MeSH terms:

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antipsychotic Agents

Antimanic Agents

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602381