Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
Not Applicable
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00602381
- Lead Sponsor
- Roxane Laboratories
- 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 fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Three period, Fourteen day washout
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Arkansas Research
🇺🇸Little Rock, Arkansas, United States
Arkansas Research🇺🇸Little Rock, Arkansas, United States