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

Launched by RANBAXY LABORATORIES LIMITED · Jan 31, 2012

Keywords

ClinConnect Summary

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 ...

Gender

MALE

Eligibility 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.