Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 1/25/2018 |
| Start Date: | April 2003 |
| End Date: | May 2003 |
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.
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.
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.
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.
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