Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 19, 2007

Last Updated Date

January 31, 2008

Start Date ^†

October 2002

Current Primary Outcome Measures ^†

Bioequivalence [ Time Frame: Baseline, Three period, Fourteen day washout ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00601575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

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

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

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Condition ^†

Bipolar Disorder

Intervention ^†

Drug: Lithium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

November 2002

Primary Completion Date

October 2002 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

25 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00601575

Responsible Party

Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.

Secondary IDs ^††

Study Sponsor ^†

Roxane Laboratories

Collaborators ^††

Investigators ^†

Principal Investigator:

Jerry Herron, MD

Arkansas Research

Information Provided By

Roxane Laboratories

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.