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Two Way Bioequivalence Study Under Fed Conditions

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Ondansetron (ODFS)

Ondansetron (ODT)

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Vimta VHS Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ondansetron (ODFS)

Zofran (ODT)

Arm Description

single dose of Ondansetron Orally Dissolving Filmstrip 8 mg

Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg

Outcomes

Primary Outcome Measures

Area Under Plasma Concentration

Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.

Secondary Outcome Measures

Full Information

NCT ID

NCT01217801

First Posted

October 7, 2010

Last Updated

March 21, 2017

Sponsor

MonoSol Rx

1. Study Identification

Unique Protocol Identification Number

NCT01217801

Brief Title

Two Way Bioequivalence Study Under Fed Conditions

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 Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MonoSol Rx

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ondansetron (ODFS)

Arm Type

Experimental

Arm Description

single dose of Ondansetron Orally Dissolving Filmstrip 8 mg

Arm Title

Zofran (ODT)

Arm Type

Active Comparator

Arm Description

Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg

Intervention Type

Drug

Intervention Name(s)

Ondansetron (ODFS)

Other Intervention Name(s)

Zuplenz

Intervention Description

Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)

Intervention Type

Drug

Intervention Name(s)

Ondansetron (ODT)

Other Intervention Name(s)

Zofran

Intervention Description

Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

Primary Outcome Measure Information:

Title

Area Under Plasma Concentration

Description

Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.

Time Frame

Day 1 and Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sudershan Vishwanath

Organizational Affiliation

Vimta VHS Research Centre

Official's Role

Study Director

Facility Information:

Facility Name

Vimta VHS Research Centre

City

Adyar

State/Province

Chenni

ZIP/Postal Code

600 113

Country

India

12. IPD Sharing Statement

Plan to Share IPD

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Two Way Bioequivalence Study Under Fed Conditions

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