Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00602394
Collaborator
(none)
30
1
Study Details
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 fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
Study Start Date
:
May 1, 2003
Actual Primary Completion Date
:
May 1, 2003
Actual Study Completion Date
:
May 1, 2003
Outcome Measures
Primary Outcome Measures
- Bioequivalence [Baseline, Two period, Fourteen day washout]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042 | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: So R Hong, MD, Novum Pharmaceutical Research Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00602394
Other Study ID Numbers:
- LITH-12
First Posted:
Jan 28, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018