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

Tracking Information

First Received Date ^ICMJE

September 19, 2007

Last Updated Date

January 31, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Bioequivalence [ Time Frame: Baseline, Three period, Fourteen day washout ]

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Bio-equivalence Study
Intervention Model:  Crossover Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2002

Primary Completion Date

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

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00601575

Responsible Party

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

Study ID Numbers ^ICMJE

LITH-09

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jerry Herron, MD

Arkansas Research

Information Provided By

Roxane Laboratories

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP