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Trial record 7 of 7 for:    aquestive

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

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Ondansetron 8 mg ODFS without water Drug: Ondansetron 8 mg ODFS with water Drug: Zofran ODT (ondansetron 8 mg) without water Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
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.
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)

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.
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)

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.
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)




Primary Outcome Measures :
  1. 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)

  2. 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")

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220167


Sponsors and Collaborators
Aquestive Therapeutics
Investigators
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Principal Investigator: Sudershan Vishwanath, MD Vimta Labs Ltd.
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Responsible Party: Aquestive Therapeutics
ClinicalTrials.gov Identifier: NCT01220167    
Other Study ID Numbers: OND/CR/051/08/09
First Posted: October 13, 2010    Key Record Dates
Results First Posted: August 18, 2020
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aquestive Therapeutics:
bioavailability
Additional relevant MeSH terms:
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Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents