Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00601536

Run by

Roxane Laboratories

People needed

29

Starts

2003-04-01

Expected to finish

2003-05-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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