Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

Completed · Not applicable

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00602381

Run by

Roxane Laboratories

People needed

30

Starts

2002-11-01

Expected to finish

2002-11-01

Last updated by the study team

2018-01-23

Who can join

Age: 25 and older, up to 45. 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…

• 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.

Where it is running

• Arkansas Research — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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