Clinical trial NCT01217190: Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nausea and Vomiting, Postoperative
Nausea With Vomiting Chemotherapy-Induced
Keywords: Bioequivalence, safety, and tolerability
Lead sponsor: Aquestive Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two period study, two treatment, randomized sequence
Primary purpose: OTHER

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

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.

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).

Primary outcomes:
measure: Cmax
timeFrame: 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
measure: AUCt
timeFrame: 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
measure: AUCinf
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Adyar
country: India
facility: VIMTA VHS Research Centre
state: Chennai
Study officials:
affiliation: Vimta Labs Ltd.
name: Sudershan Vishwanath, MD
role: PRINCIPAL_INVESTIGATOR
References: