Overview

Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed 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 (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.
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.

- 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.