Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

Roxane Laboratories

Status: Completed

Conditions: Bipolar Disorder

Treatments: Drug: Lithium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601575

LITH-09

Details and patient eligibility

About

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 fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Enrollment: 30 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)