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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00602381 |
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 |
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Bipolar Disorder |
Drug: Lithium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
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 |
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) |
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | LITH-08 |
Study First Received: | September 19, 2007 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00602381 |
Health Authority: | United States: Food and Drug Administration |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Lithium Carbonate Psychotic Disorders Lithium |
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 |