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NCT00650052 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
107
Enrollment target

NCT00650052 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 107 participants.

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The verdict

NCT00650052, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
107 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

Interventions

  • DRUG Zonisamide Capsules 100 mg
  • DRUG Zonegran® Capsules 100 mg

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2003-11
Est. Completion 2003-12
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00650052

The ClinicalTrials.gov registry entry for NCT00650052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Zonisamide Capsules 100 mg is the first listed.

NCT00650052 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00650052 about?

NCT00650052 is a clinical study titled "Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

What is the current status of trial NCT00650052?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2003-11. Estimated completion is 2003-12.

What interventions are being tested in trial NCT00650052?

The interventions under investigation include: Zonisamide Capsules 100 mg (DRUG), Zonegran® Capsules 100 mg (DRUG).

Who is sponsoring clinical trial NCT00650052?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 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.