Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

NCT ID: NCT00601575

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2002-11-30

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

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Lithium

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roxane Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Roxane Laboratories, Inc.

Principal Investigators

Jerry Herron, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Research

Locations

Arkansas Research

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

LITH-09

Identifier Type: -

Identifier Source: org_study_id