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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
ClinicalTrials.gov Identifier:
NCT01523119
First received: January 27, 2012
Last updated: February 8, 2012
Last verified: February 2012

January 27, 2012
February 8, 2012
July 2006
July 2006   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01523119 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: Ondansetron
Orally Disintegrating Tablets 8 mg
  • Active Comparator: Zofran ODT
    Zofran ODT (Ondansetron) Orally Disintegrating Tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU
    Intervention: Drug: Ondansetron
  • Experimental: Ondansetron Orally Disintegrating Tablets
    Ondansetron Orally Disintegrating Tablets 8 mg Manufactured By Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, USA)
    Intervention: Drug: Ondansetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2006
July 2006   (final data collection date for primary outcome measure)

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.
Male
18 Years to 42 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01523119
109_ONDAN_06
No
Ranbaxy Inc. ( Ranbaxy Laboratories Limited )
Ranbaxy Laboratories Limited
Not Provided
Not Provided
Ranbaxy Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP