Granisetron 1 mg Tablets, Non-fasting

NCT00834522 | Completed Phase 1 Results

• 1 other identifier: 2005-1021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 fed conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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

  Blood samples collected over 72 hour period

Study Arms (2)

Granisetron

EXPERIMENTAL

Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period

Drug: Granisetron hydrochloride 1 mg tablets

Kytril®

ACTIVE COMPARATOR

Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period

Drug: Kytril® 1 mg tablets

Interventions

Granisetron hydrochloride 1 mg tablets DRUG

2 x 1 mg, single dose non-fasting

Granisetron

Kytril® 1 mg tablets DRUG

2 x 1 mg, single dose non-fasting

Kytril®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Granisetron

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, M.D., Ph. D.

  Pharma Medica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: July 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: August 19, 2024
• Results First Posted: August 4, 2009

Record last verified: 2024-08

Locations

CA (1)