Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00602381
Collaborator
(none)
30
1
Study Details
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.
| 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, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions
Study Start Date
:
Nov 1, 2002
Actual Primary Completion Date
:
Nov 1, 2002
Actual Study Completion Date
:
Nov 1, 2002
Outcome Measures
Primary Outcome Measures
- Bioequivalence [Baseline, Three period, Fourteen day washout]
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 45 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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Research | Little Rock | Arkansas | United States | 72202 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Jerry Herron, MD, Arkansas Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00602381
Other Study ID Numbers:
- LITH-08
First Posted:
Jan 28, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018