Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

Roxane Laboratories30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder

Interventions

LithiumDRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Arkansas Research

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Three period, Fourteen day washout

Data from ClinicalTrials.gov

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