Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
This study has been completed.
Sponsor:
Roxane Laboratories
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00601575
First received: September 19, 2007
Last updated: January 31, 2008
Last verified: January 2008
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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 fed 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 Fed Conditions |
Resource links provided by NLM:
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: | October 2002 |
| Study Completion Date: | November 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 25 Years to 45 Years (Adult) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00601575
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| 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 |
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016