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Granisetron 1 mg Tablets, Non-fasting

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Granisetron hydrochloride 1 mg tablets (Drug); Kytril® 1 mg tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Xueyu (Eric) Chen, M.D., Ph. D., Principal Investigator, Affiliation: Pharma Medica

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.

Clinical Details

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax (Maximum Observed Concentration)

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pharma Medica Research Inc, Toronto, Ontario M1R 5A3, Canada
Additional Information

Starting date: July 2005
Last updated: September 1, 2009

Page last updated: August 23, 2015

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