Back to resultsBioequivalency Study of 300 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
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
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.
Sites / Locations
- Novum Pharmaceutical Research Services
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00601536
Brief Title
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 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
April 2003 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (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 the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-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
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lithium
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Fourteen day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley A Kennedy, MD
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
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