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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01523119

Healthy

COMPLETED NA

Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

NCT01511705

Healthy

COMPLETED PHASE1

Fasting Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg

NCT00649363

Healthy

COMPLETED PHASE1

Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition

NCT01511718

Healthy

COMPLETED PHASE1

Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

NCT01170169

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zofran ODT

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Orally Disintegrating Tablets 8mg

Ondansetron Orally Disintegrating Tablets

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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Orally Disintegrating Tablets 8mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ondansetron

Orally Disintegrating Tablets 8mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes