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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Ondansetron

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.