Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions
This study has been completed.
Algorithme Pharma Inc
Information provided by:
Par Pharmaceutical, Inc.
First received: April 3, 2008
Last updated: April 10, 2008
Last verified: April 2008
To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
||Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions
Primary Outcome Measures:
- Rate and Extend of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2002 (Final data collection date for primary outcome measure)
Subjects received Kali formulated products under fasting conditions
ODT, 8 mg, single-dose
Other Name: Zofran
Active Comparator: B
Subjects received GlaxoSmithKine product under fasting conditions
ODT, 8 mg, fasting conditions
Other Name: Ondansetron ODT
To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 form duly signed by the subject.
- Males and Females aged from 18 to 50 years ol 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 any 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 ECG.
- Non or ex-smokers.
- 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 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), 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 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 7.1.4).
- Positive results to HIV, HBsAg or anti-HCV tests.
- History of fainting upon blood sampling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654277
Par Pharmaceutical, Inc.
Algorithme Pharma Inc
||Algotithme Pharma Inc
No publications provided
||Dr. Alfred Elvin/ Director Biopharmacetics, Par Pharmaceutical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 3, 2008
||April 10, 2008
||United States: Institutional Review Board
Keywords provided by Par Pharmaceutical, Inc.:
To determine bioequivalence under fasting conditions
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants