Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

Not Applicable

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00602381
• Lead Sponsor: Roxane Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Three period, Fourteen day washout

Trial Locations

Locations (1)

Arkansas Research; 🇺🇸 Little Rock, Arkansas, United States