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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ondansetron (ODFS); Drug: Ondansetron (ODT)

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
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Chenni
    • Adyar, Chenni, India, 600 113
      • Vimta VHS Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under Plasma Concentration	Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.	Day 1 and Day 7

Collaborators and Investigators

• Sponsor: MonoSol Rx
• Investigators: Study Director: Sudershan Vishwanath, Vimta VHS Research Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: OND/CR/021/08-09/01906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO