NCT00649532

CompletedPhase 1

Fasting Study of Ondansetron Tablets 24 mg and Zofran® Table...

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

ONDA-0313

Study Type

interventional

Actual enrollment (reported)

28

Locations

1 country

Sites

1

Timeline

Study Start

July 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2003

Actual (reported)

Study Completion

July 2003

Actual (reported)

Brief Summary

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 fasting conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 28 participants
Study completion date: July 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2003
Actual (reported)
Study Completion
July 2003
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 24, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Ondansetron Tablets 24 mg

Drug: Ondansetron Tablets 24 mg

2

ACTIVE COMPARATOR

Zofran® Tablets 24 mg

Drug: Zofran® Tablets 24 mg

Interventions

Ondansetron Tablets 24 mgDrug

24mg, single dose fasting

1

Zofran® Tablets 24 mgDrug

24mg, single dose fasting

2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 years and older.
Sex: Male or non-pregnant, non-lactating female

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

Walter A Parham, M.D.
Cetero Research, San Antonio
PRINCIPAL INVESTIGATOR

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

July 2003

Date type not reported

This date has not been verified as actual or estimated.

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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.

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:

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

barrier methods containing or used in conjunction with a spermicidal agent, or

postmenopausal accompanied with a documented postmenopausal course of at least one year, or

surgical sterility (tubal ligation, oophorectomy or hysterectomy).

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.

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).

All subjects should be judged to be normal and healthy during a prestudy 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, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products within 1 year of the start of the study.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.
Positive test for any drug included in the urine drug screen.
Medications:
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.
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
Use of any psychotropic agents/drugs within 1 year of the start of the study.
Diseases:
History of any significant chronic disease and/or hepatitis.
History of drug and/or alcohol abuse.
History of ulceration or gastritis considered to be clinically significant.
+10 more criteria

Contact the study team to confirm eligibility.

Primary Completion

July 2003

Actual (reported)

Study Completion

July 2003

Actual (reported)

Last Updated

April 24, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00649532
Data provider: ClinicalTrials.gov
Source updated: 2024-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:12 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations