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Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01220167
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Aquestive Therapeutics

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE October 13, 2010
Results First Submitted Date  ICMJE July 25, 2011
Results First Posted Date  ICMJE August 18, 2020
Last Update Posted Date August 18, 2020
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Cmax [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose ]
    Maximum Plasma Concentration (Time to reach maximum concentration)
  • AUCt [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose ]
    Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
  • AUCinf [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose ]
    Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Official Title  ICMJE Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants
Brief Summary This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.
Detailed Description

This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered without water (Reference Treatment C) in healthy adult participants. The 3 treatment sequences were: ABC, BCA, and CAB, in which, all treatments were administered after an overnight fasting of at least 10 hours in each period.

Participants reported to the study site between 07:30 am to 04:30 pm on 22 Aug 2008, 25 Aug 2008, and 28 Aug 2008 for Period 1, Period 2, & Period 3, respectively. Participants were served dinner between 8:00 pm to 8:30 pm, to ensure a minimum of 10 hours of fasting prior to administration of a single dose of either the test or reference product. Participants were dosed as per the randomization schedule with a 3-day wash out period between each administration.

A total of 18 blood samples (4 mL each) were collected from each subject in each period for pharmacokinetic analyses. Safety assessments including monitoring of adverse events, periodic physical examination, and vital signs monitoring. Urine Drug Screening was done at the time of check-in of all the study periods to identify participants with any substance abuse. Urine pregnancy screen (for female subjects only) was scheduled at the time of screening and at admission for Period 1, Period 2, Period 3. A clinical assessment, which included general and systemic examination, was done at the pre-study screening and post study physical examination. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Ondansetron 8 mg ODFS without water
    Single dose of Ondansetron 8 mg (ODFS) administered without water
    Other Name: Test Treatment (A)
  • Drug: Ondansetron 8 mg ODFS with water
    Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water
    Other Name: Test Treatment (B)
  • Drug: Zofran ODT (ondansetron 8 mg) without water
    Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water
    Other Name: Reference Treatment (C)
Study Arms  ICMJE
  • Experimental: Sequence ABC
    Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.
    Interventions:
    • Drug: Ondansetron 8 mg ODFS without water
    • Drug: Ondansetron 8 mg ODFS with water
    • Drug: Zofran ODT (ondansetron 8 mg) without water
  • Experimental: Sequence BCA
    Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.
    Interventions:
    • Drug: Ondansetron 8 mg ODFS without water
    • Drug: Ondansetron 8 mg ODFS with water
    • Drug: Zofran ODT (ondansetron 8 mg) without water
  • Experimental: Sequence CAB
    Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.
    Interventions:
    • Drug: Ondansetron 8 mg ODFS without water
    • Drug: Ondansetron 8 mg ODFS with water
    • Drug: Zofran ODT (ondansetron 8 mg) without water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2011)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The criteria for inclusion in the study were:

  • Study volunteer should provide written informed consent.
  • Study volunteer must be a healthy adult within 18-45 years of age (inclusive).
  • Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
  • Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
  • Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
  • Study volunteer should have a normal ECG, chest X-ray and vital signs.
  • If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.

Exclusion Criteria:

The criteria for exclusion from the study were:

  • Study volunteer incapable of understanding the informed consent.
  • Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
  • Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  • Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
  • Study volunteer who smokes regularly more than ten cigarettes daily.
  • Study volunteer who has taken over the counter or prescribed medications.
  • Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01220167
Other Study ID Numbers  ICMJE OND/CR/051/08/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aquestive Therapeutics
Study Sponsor  ICMJE Aquestive Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sudershan Vishwanath, MD Vimta Labs Ltd.
PRS Account Aquestive Therapeutics
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP