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CompletedNCT00602173Updated Jan 23, 2018

Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

An interventional study of Cilostazol in Intermittent Claudication, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Intermittent Claudication
03

In context

Intermittent Claudication

254 studies on the registry are indexed under Intermittent Claudication; 45 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 199 interventional studies indexed under Intermittent Claudication.

Browse Intermittent Claudication studies →

Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to Cilostazol or any comparable or similar product.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Interventions

  • DrugCilostazol
06

What researchers measure

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Seven day washout

07

Study locations

1 site
  • CEDRA Clinical Research, LLC
    Austin, Texas 78759, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00602173
Lead sponsor
Roxane Laboratories
First posted
Jan 28, 2008
Start date
May 2003
Primary completion
May 2003
Completion
May 2003
Last update
Jan 23, 2018

Study contacts

Daniel V Freeland, DO
principal investigator · CEDRA Clinical Research, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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