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Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00602394
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : February 6, 2008
Sponsor:
Information provided by:

Study Description
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 Design

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

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 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:

  • 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

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): 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: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00602394     History of Changes
Other Study ID Numbers: LITH-12
First Posted: January 28, 2008    Key Record Dates
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