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NCT00602173 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

A NA study of Intermittent Claudication, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT00602173 is a NA study of Intermittent Claudication that has completed, run by Roxane Laboratories. The registered enrollment target is 32 participants, below the 213-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00602173, a NA study of Intermittent Claudication, has completed, sponsored by Roxane Laboratories.

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

Study Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.

Conditions Studied

Interventions

  • DRUG Cilostazol

Study Locations (1)

Texas

  • CEDRA Clinical Research, LLC - Austin

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2003-05
Est. Completion 2003-05
Phase NA

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT00602173

The ClinicalTrials.gov registry entry for NCT00602173 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 213-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (85% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Intermittent Claudication appearing as the primary indexed condition, and to 1 intervention - of which Cilostazol is the first listed.

NCT00602173 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00602173 about?

NCT00602173 is a clinical study titled "Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.

What is the current status of trial NCT00602173?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2003-05. Estimated completion is 2003-05.

What conditions does trial NCT00602173 study?

This clinical trial studies the following conditions: Intermittent Claudication.

What interventions are being tested in trial NCT00602173?

The interventions under investigation include: Cilostazol (DRUG).

Who is sponsoring clinical trial NCT00602173?

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

Where is trial NCT00602173 being conducted?

This trial has 1 study location across Texas. 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.