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