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
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Pittsburgh, Pennsylvania, United States