Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 25 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | November 2002 |
| End Date: | November 2002 |
A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions
The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate
450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg
extended release tablet under fasting conditions using a single-dose, randomized,
three-treatment, three-period, six-sequence crossover design.
450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg
extended release tablet under fasting conditions using a single-dose, randomized,
three-treatment, three-period, six-sequence crossover design.
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Participation in a clinicl trial within 30 days prior to study initiation.
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
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