Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions - Full Text View

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602394

Purpose

The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Condition	Intervention
Bipolar Disorder	Drug: Lithium

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: 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, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

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

Enrollment:	30
Study Start Date:	May 2003
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 38 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:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to lithium, or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602394

Locations

United States, Texas
Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042
Houston, Texas, United States, 77042

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

So R Hong, MD

Novum Pharmaceutical Research Services

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	LITH-12
Study First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00602394
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic
Malnutrition
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 January 14, 2009