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

NCT01523093 | Completed

• 1 other identifier: 108_ONDAN_06
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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) with Zofran ODT® 8 mg orally disintegrating tablets of GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron

  0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 20 and 24 hours

Study Arms (2)

Zofran ODT

ACTIVE COMPARATOR

Zofran ODT (Ondansetron) orally disintegrating tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU

Drug: Ondansetron

Ondansetron Orally Disintegrating Tablets

EXPERIMENTAL

Ondansetron 8 mg Orally Disintegrating Tablets Manufactured By OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA)

Drug: Ondansetron

Interventions

Ondansetron DRUG

Orally Disintegrating Tablets 8mg

Ondansetron Orally Disintegrating Tablets; Zofran ODT

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)

New Delhi, New Delhi, India

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: July 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

IN (1)