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Cross-over Bioequivalence Fasting Study to Compare Ondansetron Oral Soluble Film (OSF)With Zofran Orally Disintegrating Tablets(ODT)

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Ondansetron Orally Dissolving Film (Drug); Ondansetron Orally Disintegrating Tablet (Drug); Ondansetron OSF (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Summary

The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF 8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT (Containing Ondansetron 8 mg) (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female adult, human study participants under fasting conditions. • To monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fasting conditions.

Clinical Details

Official title: An Open-Label Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study to Compare Ondansetron OSF 8mg (Manufactured by MonoSol RX, USA) With Zofran ODT (Containing Ondansetron 8mg) (Manufactured by Cardinal Health Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo Smithkline, Research Triangle Park NC 27709, Made in England) in 48 Healthy, Adult, Human Study Participants Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Two-wy Cross-over study to Compare Ondansetron ODSF with Zofran ODT

Secondary outcome: To Access the Single dose bioequivalence of Ondansetron ODFS with Zofran ODT Under Fasting Conditions

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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 ³ 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 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 post study. Exclusion Criteria:

- Exclusion Criteria

The study participants were 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 {The normal ranges of laboratory test-values will be followed as per the clinical reference laboratory, VIMTA VHS Research Centre, Chennai (A unit of Vimta Labs Ltd., Hyderabad)}. 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.

- Study volunteer who has taken over the counter or prescribed medications, including

any enzyme modifying drugs such as Phenytoin, Carbamazepine, barbiturates, St. John wort, glucocorticoids, ketoconazole, itraconazole, erythromycin, clarithromycin and calcium channel blockers or any systemic medication within the past 30 days prior to dosing in first period 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 with urine pregnancy test

(strip method). Ondansetron 8 mg ODFS BE Fasting Study Study No.: 01905/08-09; Protocol No. : OND/CR/020/08-09 Version No.: 01 Date: 28 Jan 2009 Confidential Page 24 of 49 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 were excluded from the study. Study volunteer meeting the inclusion and exclusion criteria was verified by the medical investigator as per source documents duly authenticated by them reflecting clinical judgment as and when required.

Locations and Contacts

VIMTA VHS Research Centre, Adyar, Chennai 600 113, India
Additional Information

Starting date: September 2008
Last updated: July 25, 2011

Page last updated: August 23, 2015

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