Two Way Bioequivalence Study Under Fed Conditions

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. Identifier: NCT01217801
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Aquestive Therapeutics ( MonoSol Rx )

October 7, 2010
October 8, 2010
July 25, 2011
May 2, 2017
May 2, 2017
October 2008
October 2008   (Final data collection date for primary outcome measure)
Area Under Plasma Concentration [ Time Frame: Day 1 and Day 7 ]
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Not Provided
Complete list of historical versions of study NCT01217801 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Two Way Bioequivalence Study Under Fed Conditions
Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Ondansetron (ODFS)
    Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
    Other Name: Zuplenz
  • Drug: Ondansetron (ODT)
    Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
    Other Name: Zofran
  • Experimental: Ondansetron (ODFS)
    single dose of Ondansetron Orally Dissolving Filmstrip 8 mg
    Intervention: Drug: Ondansetron (ODFS)
  • Active Comparator: Zofran (ODT)
    Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg
    Intervention: Drug: Ondansetron (ODT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • provide written informed consent.
  • healthy adult within 18-45 years of age (inclusive).
  • Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
  • systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
  • normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
  • 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:

  • The study participants were excluded based on the following criteria:

    • incapable of understanding the informed consent.
    • history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
    • evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
    • volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma .
    • smokes regularly more than ten cigarettes daily
    • taken over the counter or prescribed medications
    • history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.
    • history of alcohol or substance abuse within the last 5 years.
    • clinically significant abnormal values of laboratory parameters.
    • positive urine screen for drugs of abuse at the time of admission check-in for each period.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Aquestive Therapeutics ( MonoSol Rx )
MonoSol Rx
Not Provided
Study Director: Sudershan Vishwanath Vimta VHS Research Centre
Aquestive Therapeutics
March 2017

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