Three-way Crossover Comparative Water-effect Bioavailability to Compare Ondansetron ODFS 8mg With and Without Water With Zofran ODT 8mg Without Water in 18 Healthy Participants Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01220167
First received: October 12, 2010
Last updated: July 25, 2011
Last verified: October 2010
  Purpose

The purpose of this study is to compare dosing effect of water on the single dose bioavailability of Ondansetron ODFS 8mg (MonoSol Rx, USA) administered with and without water to Zofran ODT® 8mg administered without water in healthy male and female adult, human study participants under fasting conditions.

  • To monitor clinical status, adverse events and laboratory investigations, and to assess the relative safety and tolerance of the study drug formulations under fasting conditions.
  • To estimate intra-subject coefficients of variation (CV).

Condition Intervention Phase
Bioavailability
Drug: Ondansetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Randomized, Single Oral Dose, Three-way Crossover Comparative Water-effect Bioavailability Study to Compare Ondansetron Orally Dissolving Filmstrop (ODFS)8mg (MonoSol Rx USA) With and Without Water With Zofran Orally Dissolving Tablets (ODT) (Containing Ondansetron 8mg) (Glaxo SmithKline, USA) Without Water in 18 Adult, Healthy Human Study Participants Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Compare effect of water on the single dose bioavailability of Ondansetron ODFS administered with and without water to Zofran ODT 8mg without water in healthy volunteers [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    To compare the effect of water on the single dose bioavailability of Ondansetron ODFS 8mg with and without water to Zofran ODT 8mg with and without water in healthy male and female human study participants under fasting conditions


Secondary Outcome Measures:
  • To monitor clinical status,adverse events and laboratory investigations, and to assess the relative safety and tolerance of the study drug formulations under fasting conditions. [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
    To monitor clinical status,adverse events and laboratory investigations, and to assess the relative safety and tolerance of the study drug formulations under fasting conditions.


Enrollment: 18
Study Start Date: August 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron Orally Dissolving Filmstrip Drug: Ondansetron

Participants were served dinner to ensure a minimum of 10 hours of fasting. Participants were dosed with a 3 day washout period between each administration.

Blood samples were obtained.

Other Names:
  • Participants were served dinner to ensure a minimum of 10 hours of fasting. Participants were dosed with a 3 day washout period between each administration.
  • Blood samples were obtained.
Active Comparator: Ondansetron Orally Disintegrating Tablet Drug: Ondansetron

Participants were served dinner to ensure a minimum of 10 hours of fasting. Participants were dosed with a 3 day washout period between each administration.

Blood samples were obtained.

Other Names:
  • Participants were served dinner to ensure a minimum of 10 hours of fasting. Participants were dosed with a 3 day washout period between each administration.
  • Blood samples were obtained.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion Criteria

The criteria for the inclusion 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. Similarly diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
  • 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.
  • Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  • 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 as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence. or is in full menopause, i.e., postmenopausal for at least 1 year. or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteers)
  • Each female study volunteer will be given a urine pregnancy test at screening, check-in for period-1, period-2 and period 3 and post study.

Exclusion Criteria:

  • Exclusion Criteria

The participants will be excluded based on the following criteria:

  • 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 by standard laboratory, imaging or monitoring procedures. Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
  • Study volunteer who smokes regularly more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period (at least 48 hours before dosing in each period and were prohibited from doing so throughout their stay at CPU and until last PK sample had been collected in each period).
  • Study volunteer who has taken over the counter or prescribed medications, including any enzyme modifying drugs (Ref: www.medicine.iupui.edu/Flockhart/clinlist.htm - 14k) or any systemic medication within the past 30 days prior to dosing in first period.
  • Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation and cooperation with the study protocol.
  • Study volunteer who has a history of alcohol or substance abuse within the last 5 years.
  • Study volunteer with clinically significant abnormal values of laboratory parameters.
  • Study volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
  • Study volunteer who is unable to or likely to be non-compliant with protocol requirements or restrictions.
  • Study volunteer in whom study drug is contraindicated for medical reasons
  • Study volunteer who is intolerant to venipuncture.
  • Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
  • Female volunteer demonstrating a positive pregnancy screen. Each female study volunteer will be screened for pregnancy at screening, check-in each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study.
  • Female volunteer who is currently breast feeding. Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study will not be allowed to participate. Female study volunteer of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or she will not be allowed to participate. Study volunteer with a positive urine screen for drugs of abuse at the time of admission check-in for each period will be excluded from the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01220167

Sponsors and Collaborators
Par Pharmaceutical, Inc.
Investigators
Principal Investigator: Sudershan Vishwanath, MD Vimta Labs Ltd.
  More Information

No publications provided

Responsible Party: Mary Ellen Norvitch, Ph.D., MonoSol Rx, LLC
ClinicalTrials.gov Identifier: NCT01220167     History of Changes
Other Study ID Numbers: OND/CR/051/08/09
Study First Received: October 12, 2010
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 01, 2014