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Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions

NCT00601536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Conditions

Interventions

DRUG

Lithium

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Shirley A Kennedy, MD · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00601536 on ClinicalTrials.gov