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

This study has been completed.

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00618254

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 fasting conditions.

Condition	Intervention
Nausea Vomiting	Drug: Granisetron

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Granisetron Granisetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Bio-equivalence Study
Official Title:	A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, four 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618254

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

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	GRAN-T1-PVFS-1
Study First Received:	January 30, 2008
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00618254
Health Authority:	United States: Institutional Review Board

Keywords provided by Roxane Laboratories:

Prevention of nausea and vomiting associated with radiation or chemotherapy

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive

Nausea
Granisetron
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Therapeutic Uses

Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009