A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions - Tabular View

Tracking Information

First Received Date ^ICMJE

January 30, 2008

Last Updated Date

February 18, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence [ Time Frame: Baseline, four period, 7 day washout ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00618254 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions

Official Title ^ICMJE

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions

Brief Summary

The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fasting conditions.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Bio-equivalence Study

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Drug: Granisetron

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to granisetron or any other comparable or similar drug.

Gender

Both

Ages

19 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00618254

Responsible Party

Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.

Study ID Numbers ^ICMJE

GRAN-T1-PVFS-1

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James Kissling, M.D.

MDS Pharma Services

Information Provided By

Roxane Laboratories

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP