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

This study has been completed.

First Received on January 30, 2008. Last Updated on February 15, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00618111

Purpose

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 fed conditions.

Condition	Intervention
Nausea Vomiting	Drug: Granisetron

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, 4-period, 7 day washout ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	March 2005
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings 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 product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618111

Locations

United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

James Kissling, M.D.

MDS Pharma Services

More Information

No publications provided

Responsible Party:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00618111 History of Changes
Other Study ID Numbers:	GRAN-T1-PVFD-1
Study First Received:	January 30, 2008
Last Updated:	February 15, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Roxane Laboratories:

Prevention of nausea and vomiting associated with radiation or chemotherapy

Additional relevant MeSH terms:

Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012