Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets (01905/08-09)

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.

Study Overview

• Status: Completed
• Conditions: Nausea With Vomiting Chemotherapy-Induced; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: Ondansetron (ODFS); Drug: Zofran (ODT)

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Chennai
    • Adyar, Chennai, India, 600 113
      • Vimta VHS Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Ondansetron (ODFS); Test Article; Other Names: Ondansetron Orally Dissolving Film Strip; Drug: Zofran (ODT); Comparator; Other Names: Zofran Orally Disintegrating Tablet
Experimental: 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	Drug: Ondansetron (ODFS); Test Article; Other Names: Ondansetron Orally Dissolving Film Strip; Drug: Zofran (ODT); Comparator; Other Names: Zofran Orally Disintegrating Tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MonoSol Rx
• Investigators: Principal Investigator: Sudershan Vishwanath, MD, Vimta Labs Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2008
• Primary Completion (Actual): September 26, 2008
• Study Completion (Actual): October 6, 2008

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Bioequivalence, safety, and tolerability
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: OND/CR/020/08-09