MedTrace Logo

Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

NCT00838630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-19

Study results available
· View outcomes & findings →

Summary

The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36 adult subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Cilostazol 100 mg tablets

1 x 100 mg

DRUG

Pletal® 100 mg tablets

1 x 100 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Steven Herrmann, M.D., Ph. D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2003-11-30
Completion
2003-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838630 on ClinicalTrials.gov