Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Lithium (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Jerry Herron, MD, Principal Investigator, Affiliation: Arkansas Research
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 25 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Arkansas Research, Little Rock, Arkansas 72202, United States
Additional Information
Starting date: November 2002
Ending date: November 2002
Last updated: January 31, 2008
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