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

Phase 1

Completed

• Conditions: Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced
• Interventions: Drug: Ondansetron (ODFS); Drug: Zofran (ODT)

• Registration Number: NCT01217190
• Lead Sponsor: MonoSol Rx

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 Timeline

• Study Start: 2008-09-16
• Primary Completion: 2008-09-26
• Study Completion: 2008-10-06
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-08
• Results First Submitted: 2017-03-21
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Results First Posted: 2020-07-29
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ondansetron ODFS then Zofran ODT	Ondansetron (ODFS)	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
Ondansetron ODFS then Zofran ODT	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
Zofran ODT then Ondansetron ODFS	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
Zofran ODT then Ondansetron ODFS	Zofran (ODT)	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

Primary Outcome Measures

Name	Time	Method
Cmax	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	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	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

Trial Locations

Locations (1)

VIMTA VHS Research Centre; 🇮🇳 Adyar, Chennai, India