Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Ondansetron Drug: Zofran®

Participant Flow

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
Ondansetron (Test) First	Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
Zofran® (Reference) First	Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period

Participant Flow for 2 periods

Period 1: First Intervention

	Ondansetron (Test) First	Zofran® (Reference) First
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Period 2: Second Intervention

	Ondansetron (Test) First	Zofran® (Reference) First
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Ondansetron (Test) First	Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
Zofran® (Reference) First	Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
Total	Total of all reporting groups

Baseline Measures

	Ondansetron (Test) First	Zofran® (Reference) First	Total
Number of Participants [units: participants]	12	12	24
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	12	12	24
>=65 years	0	0	0
Gender [units: participants]
Female	3	5	8
Male	9	7	16
Race/Ethnicity, Customized [units: Participants]
Black	4	8	12
Hispanic	5	3	8
Biracial	0	1	1
Caucasian	3	0	3
Region of Enrollment [units: participants]
United States	12	12	24

Outcome Measures

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1. Primary:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ]

Measure Type	Primary
Measure Title	Cmax - Maximum Observed Concentration
Measure Description	Bioequivalence based on Cmax
Time Frame	Blood samples collected over 24 hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data from all subjects who completed the study were included in the statistical analysis.

Reporting Groups

	Description
Ondansetron	Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
Zofran®	Zofran® 8 mg ODT (reference) dosed in either period

Measured Values

	Ondansetron	Zofran®
Number of Participants Analyzed [units: participants]	24	24
Cmax - Maximum Observed Concentration [units: ng/mL] Mean ± Standard Deviation	30.196 ± 13.378	30.892 ± 12.653

Statistical Analysis 1 for Cmax - Maximum Observed Concentration

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of Geometric Means ^[3]	97.1
90% Confidence Interval	( 91.2 to 103 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

2. Primary:

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ]

Measure Type	Primary
Measure Title	AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Measure Description	Bioequivalence based on AUC0-inf
Time Frame	Blood samples collected over 24 hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data from all subjects who completed the study were included in the statistical analysis.

Reporting Groups

	Description
Ondansetron	Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
Zofran®	Zofran® 8 mg ODT (reference) dosed in either period

Measured Values

	Ondansetron	Zofran®
Number of Participants Analyzed [units: participants]	24	24
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [units: ng*h/mL] Mean ± Standard Deviation	293.492 ± 172.394	303.106 ± 172.148

Statistical Analysis 1 for AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of Geometric Means ^[3]	95.2
90% Confidence Interval	( 88.8 to 102 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

3. Primary:

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 24 hour period ]

Measure Type	Primary
Measure Title	AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Measure Description	Bioequivalence based on AUC0-t
Time Frame	Blood samples collected over 24 hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data from all subjects who completed the study were included in the statistical analysis.

Reporting Groups

	Description
Ondansetron	Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
Zofran®	Zofran® 8 mg ODT (reference) dosed in either period

Measured Values

	Ondansetron	Zofran®
Number of Participants Analyzed [units: participants]	24	24
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [units: ng*h/mL] Mean ± Standard Deviation	270.928 ± 151.776	276.641 ± 142.500

Statistical Analysis 1 for AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of Geometric Means ^[3]	95.9
90% Confidence Interval	( 89.5 to 103 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

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: Principal Investigator is not permitted to discuss or publish trial results.

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: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00934921 History of Changes
Other Study ID Numbers:	B026528
Study First Received:	July 6, 2009
Results First Received:	July 8, 2009
Last Updated:	July 8, 2009
Health Authority:	United States: Institutional Review Board