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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced

Intervention / Treatment
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* Drug: Ondansetron (ODFS)
* Drug: Zofran (ODT)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two period study, two treatment, randomized sequence
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron ODFS then Zofran ODT<br>Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods | Drug: Ondansetron (ODFS)<br>* Test Article<br>* Other names: Ondansetron Orally Dissolving Film Strip;Drug: Zofran (ODT)<br>* Comparator<br>* Other names: Zofran Orally Disintegrating Tablet;|
| Experimental: Zofran ODT then Ondansetron ODFS<br>Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods | Drug: Ondansetron (ODFS)<br>* Test Article<br>* Other names: Ondansetron Orally Dissolving Film Strip;Drug: Zofran (ODT)<br>* Comparator<br>* Other names: Zofran Orally Disintegrating Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration) | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours | 
| AUCt | Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours | 
| AUCinf | Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, safety, and tolerability