NCT00838630

Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Cilostazol, 100 mg, Compared to an Equivalent Dose of a Commercially Available Reference Drug Product in 36 Fasted, Healthy, Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cilostazol 100 mg tablets	1 x 100 mg
DRUG	Pletal® 100 mg tablets	1 x 100 mg

Timeline

• Start date: 2003-11-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2009-02-06
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

1 site across 1 country: United States