Granisetron 1 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Granisetron hydrochloride 1 mg tablets; Drug: Kytril® 1 mg tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration)	Bioequivalence based on Cmax	Blood samples collected over 72 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 72 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]	Bioequivalence based on AUC0-t	Bl;ood samples collected over 36 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 1, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: 2005-1028