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

Nausea and Vomiting, Postoperative Clinical Trial

— 01905/08-09  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217190
• Other study ID #: OND/CR/020/08-09
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 16, 2008
• Est. completion date: October 6, 2008

Study information

• Verified date: July 2020
• Source: Aquestive Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT01216969

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 6, 2008
• Est. primary completion date: September 26, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ondansetron (ODFS)
Test Article
• Zofran (ODT)
Comparator

Locations

Country	Name	City	State
India	VIMTA VHS Research Centre	Adyar	Chennai

Sponsors (1)

Lead Sponsor	Collaborator
MonoSol Rx

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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