Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

This study has been completed.
Information provided by:
Roxane Laboratories Identifier:
First received: September 19, 2007
Last updated: January 31, 2008
Last verified: January 2008
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:

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)

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

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
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Please refer to this study by its identifier: NCT00601575

United States, Arkansas
Arkansas Research
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Jerry Herron, MD Arkansas Research
  More Information

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. 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
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 30, 2016