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NCT00648388 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg

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

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT00648388 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 44 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00648388, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

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

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.

Conditions Studied

Interventions

  • DRUG Cilostazol Tablets 100 mg
  • DRUG Pletal® Tablets 100 mg

Study Locations (1)

Missouri

  • Gateway Medical Research, Inc. - Saint Charles

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2004-03
Est. Completion 2004-05
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648388

The ClinicalTrials.gov registry entry for NCT00648388 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 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 (93% 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 Cilostazol Tablets 100 mg is the first listed.

NCT00648388 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT00648388 about?

NCT00648388 is a clinical study titled "Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.

What is the current status of trial NCT00648388?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2004-03. Estimated completion is 2004-05.

What conditions does trial NCT00648388 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00648388?

The interventions under investigation include: Cilostazol Tablets 100 mg (DRUG), Pletal® Tablets 100 mg (DRUG).

Who is sponsoring clinical trial NCT00648388?

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

Where is trial NCT00648388 being conducted?

This trial has 1 study location across Missouri. 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.