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NCT00601575 Clinical Trial

Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

Bipolar Disorder Clinical Trial

Official title:
A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601575
Other study ID # LITH-09
Secondary ID
Status Completed
Phase N/A
First received September 19, 2007
Last updated January 19, 2018
Start date October 2002
Est. completion date November 2002

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 2002
Est. primary completion date October 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lithium

Locations
Country Name City State
United States Arkansas Research Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, Three period, Fourteen day washout
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