Overview

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).