Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00934921
First received: July 6, 2009
Last updated: July 8, 2009
Last verified: July 2009

July 6, 2009
July 8, 2009
February 2003
February 2003   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00934921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions
A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions

The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Ondansetron
    1 x 8 mg Orally Disintegrating Tablet
  • Drug: Zofran®
    1 x 8 mg ODT
  • Experimental: Ondansetron
    Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
    Intervention: Drug: Ondansetron
  • Active Comparator: Zofran®
    Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
    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
24
February 2003
February 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers at least 18 years of age.
  • Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
  • All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00934921
B026528
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Solomon G Ghide, MD Novum
Teva Pharmaceuticals USA
July 2009

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