HealthyNCT01523119
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
A study testing Ondansetron in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2006to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)
New Delhi, New Delhi
About this study
Official title: 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 (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofran 8 mg ODT® Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) Manufactured by Cardinal Health, UK for GlaxoSmithKline USA, in Healthy, Adult, Human, Male Subjects Under Fed Condition.
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.
Read the 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 (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron) manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male subjects under fed condition.
During each period of the study after an overnight fast of at least 10 hours a high-fat high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, 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
- Healthy
- Being tested
- Ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Orally Disintegrating Tablets 8 mg
| Study group | Role | What they receive |
|---|---|---|
| Zofran ODT | Active comparator | Zofran ODT (Ondansetron) Orally Disintegrating Tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU Receives: Drug: Ondansetron |
| Ondansetron Orally Disintegrating Tablets | Experimental | Ondansetron Orally Disintegrating Tablets 8 mg Manufactured By Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, USA) Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron
Measured: 0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJul 2006
- Primary completionJul 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523119
- Sponsor's protocol ID
- 109_ONDAN_06
- Status last verified
- Feb 2012
- First submitted
- 27 Jan 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofran 8 mg ODT® Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) Manufactured by Cardinal Health, UK for GlaxoSmithKline USA, in Healthy, Adult, Human, Male Subjects Under Fed Condition.
- ClinicalTrials.gov ID
- NCT01523119
- Acronym / sponsor ID
- 109_ONDAN_06
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron) manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male subjects under fed condition.
During each period of the study after an overnight fast of at least 10 hours a high-fat high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, 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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zofran ODT | Active comparator | Drug: OndansetronZofran ODT (Ondansetron) Orally Disintegrating Tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU |
| Ondansetron Orally Disintegrating Tablets | Experimental | Drug: OndansetronOndansetron Orally Disintegrating Tablets 8 mg Manufactured By Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, USA) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronOrally Disintegrating Tablets 8 mg | Drug | Ondansetron Orally Disintegrating Tablets, Zofran ODT |
Primary outcome
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron
Time frame: 0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron (time frame: 0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.