Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

• Status: Completed
• Trial end date: 2008-10-06
• Target enrollment: 0
• Participant gender: All

Summary

This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MonoSol Rx; Par Pharmaceutical, Inc.
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Volunteer should have written informed consent.

• Volunteer healthy adult within 18-45 years of age (inclusive).

• Body mass index of 18.5 kg/m^2 and 25 kg/m^2, body weight not less than 50 kg.

• Volunteer must be of normal health.

• Volunteer should have a normal ECG, chest X-ray and vital signs.

• If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.

Criteria: Exclusion Criteria:

• Volunteer doesn't understand the informed consent.

• Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.

• Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures

• Volunteer who smokes regularly, alcohol or drug abuse

• Volunteer who has taken over the counter or prescribed medications

• Volunteer with clinically significant abnormal values of laboratory parameters.

• Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.

• Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).