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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
Sponsored by
Roxane Laboratories
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
September 19, 2007
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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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
No

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
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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