Expired Study
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St. Charles, Missouri 63301


The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fed conditions.


Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study. 2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following: 1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or 2. barrier methods containing or used in conjunction with a spermicidal agent, or 3. postmenopausal accompanied with a documented postmenopausal course of at least one year, or 4. surgical sterility (tubal ligation, oophorectomy or hysterectomy). 3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form. 3. Weight: At least 60 kg (132 lbs) for males and 48 kg (106 lbs) for females and all subjects within 15% of their Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 4. All subjects should be judged to be normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, and phencyclidine) performed within 14 days of the initial dose of study medication. Exclusion Criteria: 1. Institutionalized subjects will not be used. 2. Social Habits: 1. Use of any tobacco products within 1 year of the start of the study. 2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. 3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication. 4. Any recent, significant change in dietary or exercise habits. 5. Positive test for any drug included in the urine drug screen. 3. Medications: 1. Use of any medication within the 14 days prior to the initial dose of study medication. Hormonal contraceptives and hormonal replacement therapy should NOT be used within 3 months of initial study medication. 2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. 3. Use of any psychotropic agents/drugs within 1 year of the start of the study. 4. Diseases: 1. History of any significant chronic disease and/or hepatitis. 2. History of drug and/or alcohol abuse. 3. History of ulceration or gastritis considered to be clinically significant. 4. Acute illness at the time of either the pre-study medical evaluation or dosing. 5. Positive HIV, Hepatitis B or Hepatitis C test. 5. Abnormal and clinically significant laboratory test results: 1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 424 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Allergy or hypersensitivity to ondansetron or other selective serotonin receptor antagonist products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Food Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

Official Title:

Single-Dose Food In Vivo Bioequivalence Study of Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) in Healthy Volunteers

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mylan Pharmaceuticals

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Steven Herrmann, M.D., Ph.D.
Principal Investigator
Cetero Research

Study Dates

Start Date:July 2003
Completion Date:July 2003
Completion Type:Actual
Primary Completion Date:July 2003
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:March 31, 2008
First Received Date:March 30, 2008

Study Outcomes

Outcome Type:Primary Outcome
Time Frame:within 30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ondansetron Tablets 24 mg
Description:24mg, single dose fed
Arm Name:1
Intervention Type:Drug
Name:Zofran® Tablets 24 mg
Description:24mg, single dose fed
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Ondansetron Tablets 24 mg
Study Arm Type:Active Comparator
Arm Name:2
Description:Zofran® Tablets 24 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mylan Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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