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Completed Not applicable Interventional Accepts healthy volunteers

Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

ClinicalTrials.gov ID: NCT00602394

Public ClinicalTrials.gov record NCT00602394. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 4:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Study identification

NCT ID
NCT00602394
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Roxane Laboratories
Industry
Enrollment
30 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 38 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2003
Primary completion
Apr 30, 2003
Completion
Apr 30, 2003
Last update posted
Jan 22, 2018

2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042 Houston Texas 77042

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00602394, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 22, 2018 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00602394 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →