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

Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults

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.

This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.

Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

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).