Expired Study
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Pittsburgh, Pennsylvania 15206


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00601536


Primary Contact:

Principal Investigator
Shirley A Kennedy, MD
Novum Pharmaceutical Research Services


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15206
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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