Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

BioequivalenceHealthy Subjects

Outcome Measures

Primary Outcomes (3)

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Blood samples collected over 96 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUC0-inf
Blood samples collected over 96 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
Bioequivalence based on AUC0-t
Blood samples collected over 96 hour period

Study Arms (2)

1

EXPERIMENTAL

Drug: Cilostazol 100 mg tablets

2

ACTIVE COMPARATOR

Drug: Pletal® 100 mg tablets

Interventions

Cilostazol 100 mg tabletsDrug

1 x 100 mg

Pletal® 100 mg tabletsDrug

1 x 100 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Sex: Male and Female; similar proportion of each preferred. Female subjects must be surgically sterile for at least six (6) months or postmenopausal for at least one (1) year.
Age: At least 18 years.

Sponsors & Collaborators

Teva Pharmaceuticals USA
Industrylead

Study Sites (1)

Gateway Medical Research Inc.

Saint Charles, Missouri, 63301, United States

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA

Study Officials

Steven Herrmann, M.D., Ph. D.
Cetero Research, San Antonio
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

November 2003

Date type not reported

This date has not been verified as actual or estimated.

Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations