Two Way Bioequivalence Study Under Fed Conditions

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

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

Details

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

Criteria

Inclusion Criteria:

• provide written informed consent.

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

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

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

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

• 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.

Exclusion Criteria:

• The study participants were excluded based on the following criteria:

• incapable of understanding the informed consent.

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

• evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function

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

• smokes regularly more than ten cigarettes daily

• taken over the counter or prescribed medications

• history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.

• history of alcohol or substance abuse within the last 5 years.

• clinically significant abnormal values of laboratory parameters.

• positive urine screen for drugs of abuse at the time of admission check-in for each period.