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Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ondansetron (Drug); Zofran (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Christian Aumais, Principal Investigator, Affiliation: Algotithme Pharma Inc


To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg

Clinical Details

Official title: Comparative, Randomized, Single-Dose, Cross Over Bioavailability Study of Kali's Ondansetron ODT 8 mg With That of GlaxoSmithKine's Zofran ODT 8 mg in Healthy Adult Subjects Under Fed Conditions

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Rate and Extend of Absorption

Detailed description: To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Subjects meeting all of the following criteria may be included in the study

- Availability of subject for the entire study period and willingness to adhere to

protocol requirements as evidenced by the informed consent from duly signed by the subject.

- Males and females aged from 18 to 50 years with a body mass index (BMI) within 19-30;

demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.

- Clinical laboratory values within the laboratory's stated normal range; if not within

this range, they must be without ant clinical significance and must be recorded as such in the CRF ( laboratory tests are presented in section 7. 1.3)

- Healthy according to the laboratory results and physical examination.

- Normal cardiovascular function according to the to ECG.

- 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

other 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 pregnant, lactating or are likely to become pregnant during the study


- Females or childbearing potential who refuse to use an acceptable contraceptive

regimen throughout the study.

- Positive pregnancy test before and during the study.

- Maintenance therapy with any drug, or significant history of drug dependency, alcohol

abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.

- Any clinically significant illness in the previous 28 days before day 1 of this


- Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all

barbiturates, corticosteroids, phenylhydantoins, etc.)

- Participation in another clinical trial in the previous 28 days before day 1 of this


- 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 screenings of drugs of abuse (drug names are presented in section

7. 1.4).

- Positive results to HIV, HBsAg or anti-HCV tests.

- History of fainting upon blood sampling.

Locations and Contacts

Additional Information

Starting date: August 2002
Last updated: April 10, 2008

Page last updated: August 23, 2015

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