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NCT00649480 · ClinicalTrials.gov registry record · Phase 1

Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT00649480 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00649480, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

Conditions Studied

Healthy

Interventions

  • DRUG BALSALAZIDE DISODIUM CAPSULES, 750 MG
  • DRUG COLAZAL® Capsules 750 mg

Study Locations (1)

North Dakota

  • PRACS Institute Ltd. - Cetero Research - Fargo

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2007-01
Est. Completion 2007-02
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

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What the Registry Record Tells You About NCT00649480

The ClinicalTrials.gov registry entry for NCT00649480 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which BALSALAZIDE DISODIUM CAPSULES, 750 MG is the first listed.

NCT00649480 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.

Frequently Asked Questions

What is clinical trial NCT00649480 about?

NCT00649480 is a clinical study titled "Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg". The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

What is the current status of trial NCT00649480?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2007-01. Estimated completion is 2007-02.

What conditions does trial NCT00649480 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00649480?

The interventions under investigation include: BALSALAZIDE DISODIUM CAPSULES, 750 MG (DRUG), COLAZAL® Capsules 750 mg (DRUG).

Who is sponsoring clinical trial NCT00649480?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00649480 being conducted?

This trial has 1 study location across North Dakota. 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.