Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT01046253

First received: January 8, 2010

Last updated: November 22, 2010

Last verified: November 2010

History of Changes

Results First Received: February 22, 2010

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

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
Test (Lansoprazole) First	30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
Reference (Prevacid®) First	30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.

Participant Flow for 7 periods

Period 1: First Intervention

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Period 2: First Washout of 7 Days

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Period 3: Second Intervention

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	25
COMPLETED	25	23
NOT COMPLETED	0	2
Adverse Event	0	1
Protocol Violation	0	1

Period 4: Second Washout of 7 Days

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Period 5: Third Intervention

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Period 6: Third Washout of 7 Days

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Period 7: Fourth Intervention

	Test (Lansoprazole) First	Reference (Prevacid®) First
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Test (Lansoprazole) First	30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
Reference (Prevacid®) First	30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
Total	Total of all reporting groups

Baseline Measures

	Test (Lansoprazole) First	Reference (Prevacid®) First	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	25	25	50
>=65 years	0	0	0
Gender [units: participants]
Female	6	12	18
Male	19	13	32
Race/Ethnicity, Customized [units: participants]
Black	1	4	5
Caucasian	24	20	44
Other	0	1	1
Region of Enrollment [units: participants]
United States	25	25	50

Outcome Measures

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1. Primary:

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ 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. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).

Reporting Groups

	Description
Test (Lansoprazole)	30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
Reference (Prevacid®)	30 mg Prevacid® Capsules reference product dosed in any period.

Measured Values

	Test (Lansoprazole)	Reference (Prevacid®)
Number of Participants Analyzed [units: participants]	96	96
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [units: ng*h/mL] Mean ± Standard Deviation	1998.063 ± 1310.811	2052.519 ± 1467.575

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
Slope ^[3]	98
90% Confidence Interval	( 92.8 to 104 )

[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:
	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
[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
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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:	NCT01046253 History of Changes
Other Study ID Numbers:	B036579
Study First Received:	January 8, 2010
Results First Received:	February 22, 2010
Last Updated:	November 22, 2010
Health Authority:	United States: Institutional Review Board

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