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Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00601575

First Posted: January 28, 2008

Last Update Posted: February 6, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Roxane Laboratories

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 Intervention Model: Crossover Assignment Masking: None (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:

Genetics Home Reference related topics: bipolar disorder

MedlinePlus related topics: 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 ]


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	25 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


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
First Submitted:	September 19, 2007
First Posted:	January 28, 2008
Last Update Posted:	February 6, 2008
Last Verified:	January 2008

Additional relevant MeSH terms:


Bipolar Disorder Bipolar and Related Disorders Mental Disorders Lithium Carbonate Antidepressive Agents Psychotropic Drugs	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs

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