Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions

February 8, 2012 updated by: Ranbaxy Laboratories Limited

An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Ondansetron 8 mg Orally Disintegrating Tablets of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofran 8 mg ODT® Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) Manufactured by Cardinal Health, UK for GlaxoSmithKline USA, in Healthy, Adult, Human, Male Subjects Under Fed Condition.

The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal health, UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron) manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male subjects under fed condition.

During each period of the study after an overnight fast of at least 10 hours a high-fat high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, a single oral dose of either test or reference product was administered by placing the tablet on tongue till it dissolved and then swallowed it using 240 mL of drinking water at ambient temperature under supervision of a medical officer.

During the course of the study, safety parameters including vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) were assessed and laboratory parameters of hematology and biochemistry were repeated at the end of the study.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India
        • Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Were in the age range of 18-45 years.

  • Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  • Had voluntarily given written informed consent to participate in this study.
  • Had a non-vegetarian diet habit.
  • Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

History of allergy or hypersensitivity to Ondansetron, related drugs or any other serotonin receptor blocker drugs

  • History of hiccups
  • History of urticarial reaction, rash on exposure to any drug.
  • History of anaphylaxis, angina, seizures, extrapyramidal symptoms, recent history of dizziness.
  • History of recurrent episodes of headache.
  • History of hepatitis, phenylketonuria, recent history of constipation.
  • History of bronchospasm, asthma, shortness of breath.
  • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  • Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  • Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  • Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (> 4/HPF), epithelial cells (> 4/HPF), glucose (positive) or protein (positive).
  • Clinically abnormal ECG or Chest X-ray.
  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  • History of any psychiatric illness, which might impair the ability to provide written informed consent.
  • Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
  • History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
  • Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  • Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Zofran ODT
Zofran ODT (Ondansetron) Orally Disintegrating Tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU
Drug: Ondansetron
Orally Disintegrating Tablets 8 mg
EXPERIMENTAL: Ondansetron Orally Disintegrating Tablets
Ondansetron Orally Disintegrating Tablets 8 mg Manufactured By Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, USA)
Drug: Ondansetron
Orally Disintegrating Tablets 8 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron
Time Frame: 0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours.
0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109_ONDAN_06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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