Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
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| ClinicalTrials.gov Identifier: NCT00601575 |
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Recruitment Status :
Completed
First Posted : January 28, 2008
Last Update Posted : January 23, 2018
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Sponsor:
Roxane Laboratories
Information provided by:
West-Ward Pharmaceutical
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Lithium | Not Applicable |
| 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, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | October 2002 |
| Actual Study Completion Date : | November 2002 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Bipolar disorder
MedlinePlus related topics:
Malnutrition
U.S. FDA Resources
Primary Outcome Measures :
- Bioequivalence [ Time Frame: Baseline, Three period, Fourteen day washout ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 25 Years to 45 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:
- 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.
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): NCT00601575
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 |
| Responsible Party: | Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00601575 History of Changes |
| Other Study ID Numbers: |
LITH-09 |
| First Posted: | January 28, 2008 Key Record Dates |
| Last Update Posted: | January 23, 2018 |
| Last Verified: | January 2018 |
Additional relevant MeSH terms:
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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 |