Overview

Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

Status:
Completed
Trial end date:
2002-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Roxane Laboratories
Treatments:
Lithium Carbonate
Criteria
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.