Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving Filmstrip 8mg With Zofran Orally Disintegrating Tablets in 48 Participants Under Fed Conditions

Bioavailability Clinical Trial

Official title:

An Open-label Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip (ODFS) 8mg (Manufactured by MonoSol Rx, USA) With Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] (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 Fed Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217801
• Other study ID #: OND/CR/021/08-09/01906
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2010
• Last updated: June 16, 2011

Study information

• Verified date: June 2011
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 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 fed conditions.

• To monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 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:

• 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, diagnosed 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). 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.

Study Design

N/A

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Ondansetron

• Ondansetron

Locations

Country	Name	City	State
India	Vimta VHS Research Centre	Adyar	Chenni

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	MonoSol Rx

Country where clinical trial is conducted

India,