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Bioequivalency Study of 300 mg Lithium Carbonate Under Fed 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):
So R Hong, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services


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 fed 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 Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence


Minimum age: 18 Years. Maximum age: 38 Years. Gender(s): Both.


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


Locations and Contacts

Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042, Houston, Texas 77042, United States
Additional Information

Starting date: May 2003
Last updated: January 31, 2008

Page last updated: August 23, 2015

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