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

NCT ID: NCT01217190

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-16
• Study Completion Date: 2008-10-06

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ondansetron (ODFS)

Intervention Type: DRUG

Test Article

Zofran (ODT)

Intervention Type: DRUG

Comparator

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

Group Type: EXPERIMENTAL

Ondansetron (ODFS)

Intervention Type: DRUG

Test Article

Zofran (ODT)

Intervention Type: DRUG

Comparator

Interventions

Ondansetron (ODFS)

Test Article

Intervention Type: DRUG

Zofran (ODT)

Comparator

Intervention Type: DRUG

Other Intervention Names

Ondansetron Orally Dissolving Film Strip; Zofran Orally Disintegrating Tablet

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MonoSol Rx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sudershan Vishwanath, MD

Role: PRINCIPAL_INVESTIGATOR

Vimta Labs Ltd.

Locations

VIMTA VHS Research Centre

Adyār, Chennai, India

Countries

India

Other Identifiers

OND/CR/020/08-09

Identifier Type: -

Identifier Source: org_study_id

NCT01216969

Identifier Type: -

Identifier Source: nct_alias