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Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00602381
First received: September 19, 2007
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  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

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 Fasting Conditions

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
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: 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

No publications provided

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00602381     History of Changes
Other Study ID Numbers: LITH-08
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
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013