Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00659685 |
Recruitment Status
:
Completed
First Posted
: April 16, 2008
Last Update Posted
: April 16, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Ondansetron Drug: Zofran ODT | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 16 mg ODT With That of GlaxoSmithKine's Zofran 16 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions |
Study Start Date : | November 2003 |
Arm | Intervention/treatment |
---|---|
Experimental: A
Subjects received Kali formulated products under fasting conditions
|
Drug: Ondansetron
ODT, single-dose, fasting
Other Name: Zofran ODT
|
Active Comparator: B
Subjects received GlaxoSmithKline formulated products under fasting conditions
|
Drug: Zofran ODT
Other Name: Ondansetron ODT
|
- Rate and Extend of absorption [ Time Frame: 24 Hours ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer
- Males and females aged between 18 and 55 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/ m2
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3)
- Healthy according to the laboratory results and physical examination.
- Non- or ex- smokers
Exclusion Criteria:
- Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- Females who are pregnant, lactating or are likely to become pregnant during the study phases.
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
- Positive serum pregnancy test before and during the study.
- Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
- Any clinically significant illness in the previous 28 days before day 1 of this study.
- Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
- Participation in another clinical trial in the previous 28 days before day 1 of this study.
- Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
- Positive urine screening of drugs of abuse (drug names are presented in section 6.1.1.4).
- Positive results to HIV, HBsAg or anti-HCV tests.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659685
Canada, Quebec | |
Algorithme Pharma | |
Laval, Quebec, Canada, H4N 2Y8 |
Principal Investigator: | Christian Aumais | Algotithme Pharma Inc |
Responsible Party: | Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00659685 History of Changes |
Other Study ID Numbers: |
ODO-P3-265 |
First Posted: | April 16, 2008 Key Record Dates |
Last Update Posted: | April 16, 2008 |
Last Verified: | March 2008 |
Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence Ondansetron ODT Fasting To Determine Bioequivalence Under Fasting conditions |
Additional relevant MeSH terms:
Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |