Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT00834795

First received: January 30, 2009

Last updated: September 11, 2009

Last verified: September 2009

History of Changes

Results First Received: May 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Carvedilol 25 mg tablets Drug: COREG® 25 mg tablets

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
Carvedilol (Test) First	Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Coreg® (Reference) First	Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

Period 1: First Intervention

	Carvedilol (Test) First	Coreg® (Reference) First
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Period 2: Washout: 7 Days

	Carvedilol (Test) First	Coreg® (Reference) First
STARTED	18	18
COMPLETED	18	17
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Period 3: Second Intervention

	Carvedilol (Test) First	Coreg® (Reference) First
STARTED	18	17
COMPLETED	17	17
NOT COMPLETED	1	0
Adverse Event	1	0

Baseline Characteristics

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Reporting Groups

	Description
Carvedilol (Test) First	Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Coreg® (Reference) First	Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
Total	Total of all reporting groups

Baseline Measures

	Carvedilol (Test) First	Coreg® (Reference) First	Total
Number of Participants [units: participants]	18	18	36
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	18	18	36
>=65 years	0	0	0
Gender [units: participants]
Female	10	6	16
Male	8	12	20
Race/Ethnicity, Customized [units: Participants]
Caucasian	16	13	29
Black	1	5	6
Asian	1	0	1
Region of Enrollment [units: participants]
United States	18	18	36

Outcome Measures

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1. Primary:

Cmax - Maximum Observed Concentration - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ]

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2. Primary:

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ]

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3. Primary:

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ]

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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) - Carvedilol in Plasma
Measure Description	Bioequivalence based on AUC0-t
Time Frame	Blood samples collected over 60 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
Carvedilol	Carvedilol 25 mg Tablet (test) dosed in either period
Coreg®	Coreg® 25 mg Tablet (reference) dosed in either period

Measured Values

	Carvedilol	Coreg®
Number of Participants Analyzed [units: participants]	34	34
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma [units: ng*h/mL] Mean ± Standard Deviation	454.24 ± 303.44	456.05 ± 279.95

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

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Test/Ref Ratio of LS Means x 100 ^[3]	96.36
90% Confidence Interval	( 90.20 to 102.93 )

[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:
	Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
[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:	NCT00834795 History of Changes
Other Study ID Numbers:	01268
Study First Received:	January 30, 2009
Results First Received:	May 8, 2009
Last Updated:	September 11, 2009
Health Authority:	United States: Institutional Review Board

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