Granisetron 1 mg Tablets Under Fasting Conditions - Full Text View

Purpose

The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Granisetron hydrochloride 1 mg tablets Drug: Kytril® 1 mg tablets	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Granisetron hydrochloride Granisetron

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:

Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] [ Time Frame: Bl;ood samples collected over 36 hour period ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Granisetron Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period	Drug: Granisetron hydrochloride 1 mg tablets 2 x 1 mg, single dose fasting
Active Comparator: Kytril® Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period	Drug: Kytril® 1 mg tablets 2 x 1 mg, single dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, non-smoking, male and female subjects, 18 years of age or older.
BMI ≥ 19 and ≤ 30.
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.
No clinically significant findings in the 12-lead electrocardiogram (ECG).
No clinically significant findings from the vital signs measurement.
Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Negative for:

HIV.
Hepatitis B surface antigen and Hepatitis C antibody.
Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
Urine cotinine test.
Serum HCG consistent with pregnancy (females only).

Females who participate in this study are:

unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) OR
willing to remain abstinent [not engage in sexual intercourse] OR
willing to use an effective method of double-barrier birth control [partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD]
Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation).
Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing OR females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
Difficulty fasting or consuming the standard meals.
Do not tolerate venipuncture.
Unable to read or sign the ICF.

Known history or presence of:

Hypersensitivity or idiosyncratic reaction to granisetron hydrochloride and/or any other drug substances with similar activity.
Alcoholism within the last 12 months.
Drug dependence and/or substance abuse.
Use of tobacco or nicotine-containing products, within the last 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834717

Locations

Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R5A3

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

Principal Investigator:

Xueyu (Eric) Chen, M.D., Ph. D.

Pharma Medica

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00834717 History of Changes
Other Study ID Numbers:	2005-1028
Study First Received:	January 30, 2009
Results First Received:	June 30, 2009
Last Updated:	September 1, 2009
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:

Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:

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 June 13, 2013