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 )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ondansetron (ODFS) Drug: Ondansetron (ODT) Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Ondansetron (ODFS)
single dose of Ondansetron Orally Dissolving Filmstrip 8 mg
Drug: Ondansetron (ODFS)
Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
Other Name: Zuplenz

Active Comparator: Zofran (ODT)
Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg
Drug: Ondansetron (ODT)
Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
Other Name: Zofran

Primary Outcome Measures :
  1. Area Under Plasma Concentration [ Time Frame: Day 1 and Day 7 ]
    Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.

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

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.

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 identifier (NCT number): NCT01217801

Vimta VHS Research Centre
Adyar, Chenni, India, 600 113
Sponsors and Collaborators
MonoSol Rx
Study Director: Sudershan Vishwanath Vimta VHS Research Centre

Responsible Party: MonoSol Rx Identifier: NCT01217801     History of Changes
Other Study ID Numbers: OND/CR/021/08-09/01906
First Posted: October 8, 2010    Key Record Dates
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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