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NCT00602394 Clinical Trial

Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

Bipolar Disorder Clinical Trial

Official title:
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00602394
Other study ID # LITH-12
Secondary ID
Status Completed
Phase N/A
First received January 15, 2008
Last updated January 19, 2018
Start date May 2003
Est. completion date May 2003

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 the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

- Positive test for HIV, Hepatitis B, or Hepatitis C.

- Treatment with known enzyme altering drugs.

- History of allergic or adverse response to lithium, or any comparable or similar product.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lithium

Locations
Country Name City State
United States Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042 Houston Texas

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, Two period, Fourteen day washout
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