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Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lithium

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arkansas Research

Outcomes

Primary Outcome Measures

Bioequivalence

Secondary Outcome Measures

Full Information

NCT ID

NCT00602381

First Posted

September 19, 2007

Last Updated

January 19, 2018

Sponsor

Roxane Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00602381

Brief Title

Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

November 2002 (Actual)

Study Completion Date

November 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Roxane Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lithium

Primary Outcome Measure Information:

Title

Bioequivalence

Time Frame

Baseline, Three period, Fourteen day washout

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry Herron, MD

Organizational Affiliation

Arkansas Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arkansas Research

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

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