Status:
COMPLETED
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-39 years
Phase:
NA
Brief 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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01523093
Start Date
July 1 2006
End Date
October 1 2006
Last Update
February 9 2012
Active Locations (1)
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1
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, New Delhi, India