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NCT00618228 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

A NA study, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
52
Enrollment target

NCT00618228 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 52 participants.

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The verdict

NCT00618228, a NA study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
52 participants
Enrollment target

Study Summary

The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.

Interventions

  • DRUG Balsalazide

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2004-01
Est. Completion 2004-01
Phase NA

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT00618228

The ClinicalTrials.gov registry entry for NCT00618228 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Balsalazide is the first listed.

NCT00618228 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00618228 about?

NCT00618228 is a clinical study titled "Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions". The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.

What is the current status of trial NCT00618228?

This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2004-01. Estimated completion is 2004-01.

What interventions are being tested in trial NCT00618228?

The interventions under investigation include: Balsalazide (DRUG).

Who is sponsoring clinical trial NCT00618228?

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

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.