- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523093
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
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,) With Zofran ODT® 8 mg Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) of GlaxoSmithKline in Healthy, Adult, Human, Male Subjects Under Fasting Condition.
Study Overview
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 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 by placing the tablet on tongue till it dissolved and then swallowed it using 240 mL of drinking water at ambient temperature under supervision of a medical officer.
During the course of the study, safety parameters including vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) were assessed and laboratory parameters of hematology and biochemistry were repeated at the end of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Delhi, India
- Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zofran ODT
Zofran ODT (Ondansetron) orally disintegrating tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU
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Orally Disintegrating Tablets 8mg
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Experimental: Ondansetron Orally Disintegrating Tablets
Ondansetron 8 mg Orally Disintegrating Tablets Manufactured By OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA)
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Orally Disintegrating Tablets 8mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- 108_ONDAN_06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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