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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
ClinicalTrials.gov Identifier:
NCT01523093
First received: January 27, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Healthy
Drug: Ondansetron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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 Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc,) With Zofran ODT® 8 mg Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) of GlaxoSmithKline in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 20 and 24 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2006
Study Completion Date: October 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 8mg
Experimental: Ondansetron Orally Disintegrating Tablets
Ondansetron 8 mg Orally Disintegrating Tablets Manufactured By OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA)
Drug: Ondansetron
Orally Disintegrating Tablets 8mg

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 Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® orally disintegrating tablets (containing 8 mg of ondansetron) of GlaxoSmithKline in healthy, adult, human, male subjects under fasting condition.

During each period of the study after an overnight fast of at least 10 hours, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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:

  • Had history of allergy or hypersensitivity to ondansetron, related drugs or any other serotonin receptor blocker drugs.
  • Had history of dizziness, seizures or extrapyramidal symptoms.
  • Had history of urticarial reaction or rash on exposure to any drug.
  • Had history of anaphylaxis or angina (chest pain).
  • Had history of hepatitis, constipation or phenylketonuria.
  • Had history of recurrent episodes of headache.
  • Had history of bronchospasm, asthma or shortness of breath.
  • Had history of hiccups.
  • Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Had 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.
  • Was positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  • Had 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.
  • Had 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).
  • Had clinically abnormal ECG or Chest X-ray.
  • Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
  • Had history of any psychiatric illness, which might have impair the ability to provide written informed consent.
  • Was regular smokers who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  • Had history of drug dependence or had 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.
  • Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Had participated in any clinical trial within 12 weeks preceding Day 1 of this study.
  • Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523093

Locations
India
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, India
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
ClinicalTrials.gov Identifier: NCT01523093     History of Changes
Other Study ID Numbers: 108_ONDAN_06
Study First Received: January 27, 2012
Last Updated: February 8, 2012
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Ondansetron
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014