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NCT00602381 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

A NA study of Bipolar Disorder, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT00602381 is a NA study of Bipolar Disorder that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00602381, a NA study of Bipolar Disorder, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

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

Conditions Studied

Bipolar Disorder

Interventions

  • DRUG Lithium

Study Locations (1)

Arkansas

  • Arkansas Research - Little Rock

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2002-11
Est. Completion 2002-11
Phase NA

Sponsor

Roxane Laboratories

93 total trials

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What the Registry Record Tells You About NCT00602381

The ClinicalTrials.gov registry entry for NCT00602381 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Lithium is the first listed.

NCT00602381 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.

Frequently Asked Questions

What is clinical trial NCT00602381 about?

NCT00602381 is a clinical study titled "Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions". 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 fasting conditions using a single-dose, randomized, three-treatment, three-period, s...

What is the current status of trial NCT00602381?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2002-11. Estimated completion is 2002-11.

What conditions does trial NCT00602381 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00602381?

The interventions under investigation include: Lithium (DRUG).

Who is sponsoring clinical trial NCT00602381?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00602381 being conducted?

This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.