Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00601536
• Date of registration: 15/01/2008
• Primary sponsor: Roxane Laboratories
• Public title: Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
• Scientific title: A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.
• Date of first enrolment: April 2003
• Target sample size: 29
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00601536
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Shirley A Kennedy, MD
• Affiliation: Novum Pharmaceutical Research Services

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 39 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Intervention(s)

Drug: Lithium

Primary Outcome(s)

Bioequivalence [Time Frame: Baseline, Two period, Fourteen day washout]

Secondary ID(s)

LITH-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors