Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Lithium (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Shirley A Kennedy, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
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.
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Both.
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.
Locations and Contacts
Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania 15206, United States
Additional Information
Starting date: April 2003
Last updated: January 31, 2008
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