Bioequivalence of Two Formulations of Ondansetron in Healthy Adults

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00972595

First received: September 3, 2009

Last updated: June 22, 2010

Last verified: June 2010

History of Changes

Results First Received: May 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chemotherapy-Induced Nausea and Vomiting
Interventions:	Drug: ondansetron clinical trial formulation Drug: ondansetron marketed formulation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
OE U.K. Tablet Then U.K. Tablet	Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
U.K. Tablet Then OE U.K. Tablet	U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally

Participant Flow for 2 periods

Period 1: Period 1

	OE U.K. Tablet Then U.K. Tablet	U.K. Tablet Then OE U.K. Tablet
STARTED	23	22
COMPLETED	22	22
NOT COMPLETED	1	0
Adverse Event	1	0

Period 2: Period 2

	OE U.K. Tablet Then U.K. Tablet	U.K. Tablet Then OE U.K. Tablet
STARTED	22	22
COMPLETED	22	22
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	All Randomized Participants

Baseline Measures

	All Participants
Number of Participants [units: participants]	45
Age [units: Years] Mean ( Full Range )	34 ( 18 to 54 )
Gender [units: participants]
Female	26
Male	19
Height [units: Centimeters] Mean ( Full Range )	170.8 ( 154.9 to 188.0 )
Weight [units: Killograms] Mean ( Full Range )	72.0 ( 45.5 to 102.7 )

Outcome Measures

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1. Primary:

Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose ]

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2. Primary:

Peak Plasma Concentration (Cmax) for Ondansetron [ Time Frame: 24 hours post-dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00972595 History of Changes
Other Study ID Numbers:	2009_657, MK0869-106
Study First Received:	September 3, 2009
Results First Received:	May 19, 2010
Last Updated:	June 22, 2010
Health Authority:	United States: Food and Drug Administration

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