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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief 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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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).
Arms & Interventions
Ondansetron ODFS then Zofran ODT
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
Intervention: Ondansetron (ODFS) (Drug)
Ondansetron ODFS then Zofran ODT
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
Intervention: Zofran (ODT) (Drug)
Zofran ODT then Ondansetron ODFS
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
Intervention: Ondansetron (ODFS) (Drug)
Zofran ODT then Ondansetron ODFS
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
Intervention: Zofran (ODT) (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: 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
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
AUCt
Time Frame: 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
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
AUCinf
Time Frame: 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
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Secondary Outcomes
No secondary outcomes reported