Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
Not Applicable
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00601536
- Lead Sponsor
- Roxane Laboratories
- 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 fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Two period, Fourteen day washout
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie lithium carbonate's efficacy in bipolar disorder treatment?
How does the bioavailability of lithium carbonate extended release compare to immediate release formulations in bipolar disorder?
Which biomarkers are associated with lithium response prediction in bipolar disorder patients?
What are the adverse event profiles of lithium carbonate versus other mood stabilizers in bipolar disorder management?
How do lithium carbonate formulations compare to valproate or atypical antipsychotics in long-term bipolar disorder treatment effectiveness?
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Pittsburgh, Pennsylvania, United States
Novum Pharmaceutical Research Services🇺🇸Pittsburgh, Pennsylvania, United States