Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

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. Identifier: NCT00602394
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 23, 2018
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment
Bipolar Disorder Drug: Lithium

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
Study Start Date : May 2003
Primary Completion Date : May 2003
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, Two period, Fourteen day washout ]

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:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
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:

  • 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.

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 identifier (NCT number): NCT00602394

United States, Texas
Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: So R Hong, MD Novum Pharmaceutical Research Services

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. Identifier: NCT00602394     History of Changes
Other Study ID Numbers: LITH-12
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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