Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

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

Details

• Lead Sponsor: Aquestive Therapeutics; Par Pharmaceutical, Inc.
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

The criteria for inclusion in the study were:

• Study volunteer should provide written informed consent.

• Study volunteer must be a healthy adult within 18-45 years of age (inclusive).

• Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.

• Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.

• Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.

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

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

Exclusion Criteria:

The criteria for exclusion from the study were:

• Study volunteer incapable of understanding the informed consent.

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

• Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.

• Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma

• Study volunteer who smokes regularly more than ten cigarettes daily.

• Study volunteer who has taken over the counter or prescribed medications.

• Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.