Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT00835354

First received: January 30, 2009

Last updated: August 14, 2009

Last verified: August 2009

History of Changes

Results First Received: June 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Cefprozil for oral suspension 250 mg/5 mL Drug: CEFZIL® for Oral Suspension 250 mg/5mL

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
No text entered.

Reporting Groups

	Description
Cefprozil (Test) First	250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
Cefzil® (Reference) First	250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.

Participant Flow for 3 periods

Period 1: First Intervention

	Cefprozil (Test) First	Cefzil® (Reference) First
STARTED	13	13
COMPLETED	13	12
NOT COMPLETED	0	1
Adverse Event	0	1

Period 2: Washout of 7 Days

	Cefprozil (Test) First	Cefzil® (Reference) First
STARTED	13	12
COMPLETED	13	12
NOT COMPLETED	0	0

Period 3: Second Intervention

	Cefprozil (Test) First	Cefzil® (Reference) First
STARTED	13	12
COMPLETED	13	12
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Cefprozil (Test) First	250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
Cefzil® (Reference) First	250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
Total	Total of all reporting groups

Baseline Measures

	Cefprozil (Test) First	Cefzil® (Reference) First	Total
Number of Participants [units: participants]	13	13	26
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	13	13	26
>=65 years	0	0	0
Gender [units: participants]
Female	8	5	13
Male	5	8	13
Race/Ethnicity, Customized [units: participants]
Black	2	0	2
White	11	13	24
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	0	1	1
Not Hispanic or Latino	13	12	25
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	13	13	26

Outcome Measures

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1. Primary:

Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ]

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2. Primary:

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ]

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3. Primary:

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ]

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Measure Type	Primary
Measure Title	AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Measure Description	Bioequivalence based on AUC0-inf.
Time Frame	Blood samples collected over a 12 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.
All participants that completed the study had their samples analyzed.

Reporting Groups

	Description
Cefprozil (Test)	250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
Cefzil® (Reference)	250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.

Measured Values

	Cefprozil (Test)	Cefzil® (Reference)
Number of Participants Analyzed [units: participants]	25	25
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [units: ng*h/mL] Mean ± Standard Deviation	14.495 ± 2.204	16.048 ± 2.72

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

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of the T/R geometric mean x 100 ^[3]	90.7
90% Confidence Interval	( 89.1 to 92.3 )

[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:
	The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
[3]	Other relevant estimation information:
	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 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: The 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
No text entered.

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:	NCT00835354 History of Changes
Other Study ID Numbers:	B036559
Study First Received:	January 30, 2009
Results First Received:	June 18, 2009
Last Updated:	August 14, 2009
Health Authority:	United States: Institutional Review Board

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