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Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653458
First Posted: April 7, 2008
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
April 4, 2008
April 7, 2008
April 11, 2008
August 2002
September 2002   (Final data collection date for primary outcome measure)
Rate and Extend of Absorption [ Time Frame: 24 Hours ]
Same as current
Complete list of historical versions of study NCT00653458 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions
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
To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg
To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Ondansetron
    ODT, 8 mg, single-dose, fed conditions
    Other Name: Zofran ODT
  • Drug: Zofran
    ODT, 8 mg, single-dose, under fed conditions
    Other Name: Ondansetron ODT
  • Experimental: A
    Subjects received Kali formulated products under fed conditions
    Intervention: Drug: Ondansetron
  • Active Comparator: B
    Subjects received GlaxoSmithKline's formulated products under fed conditions
    Intervention: Drug: Zofran
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2002
September 2002   (Final data collection date for primary outcome measure)

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 phases.
  • 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 study.
  • 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 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 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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00653458
ODO-P2-159
No
Not Provided
Not Provided
Dr.Alfred Elvin/ Diector Biopharmaceutics, Par Pharmaceutical, Inc.
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
Principal Investigator: Christian Aumais Algotithme Pharma Inc
Par Pharmaceutical, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP