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Lansoprazole 30 mg DR Capsule Fasting Study

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01045967
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
No text entered.

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 DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
Reference (Prevacid®) First 30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Test (Lansoprazole) First     Reference (Prevacid®) First  
STARTED     28     28  
COMPLETED     28     28  
NOT COMPLETED     0     0  

Period 2:   Washout of 7 Days
    Test (Lansoprazole) First     Reference (Prevacid®) First  
STARTED     28     28  
COMPLETED     28     28  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Test (Lansoprazole) First     Reference (Prevacid®) First  
STARTED     28     28 [1]
COMPLETED     28     27  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  
[1] Subject was dropped prior to dosing in Period II due to positive drug screen.



  Baseline Characteristics
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Reporting Groups
  Description
Test (Lansoprazole) First 30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
Reference (Prevacid®) First 30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Test (Lansoprazole) First     Reference (Prevacid®) First     Total  
Number of Participants  
[units: participants]
 		  28     28     56  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     28     28     56  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     12     14     26  
Male     16     14     30  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     27     27     54  
Asian     1     0     1  
Hispanic     0     1     1  
Region of Enrollment  
[units: participants]
 		     
United States     28     28     56  



  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. ]

Measure Type Primary
Measure Title Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Measure Description Bioequivalence based on Cmax.
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
Test (Lansoprazole) 30 mg Lansoprazole DR Capsules test product dosed in either period.
Reference (Prevacid®) 30 mg Prevacid® DR Capsules reference product dosed in either period.

Measured Values
    Test (Lansoprazole)     Reference (Prevacid®)  
Number of Participants Analyzed  
[units: participants]
 		  55     55  
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)  
[units: ng/mL]
Mean ± Standard Deviation 		  939.025  ± 438.28     865.678  ± 359.365  


Statistical Analysis 1 for Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Ratio of the T/R geometric mean x 100 [3] 105
90% Confidence Interval ( 90.7 to 122 )
[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%.



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. ]

Measure Type Primary
Measure Title AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Measure Description Bioequivalence based on AUC0-t.
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
Test (Lansoprazole) 30 mg Lansoprazole DR Capsules test product dosed in either period.
Reference (Prevacid®) 30 mg Prevacid® DR Capsules reference product dosed in either period.

Measured Values
    Test (Lansoprazole)     Reference (Prevacid®)  
Number of Participants Analyzed  
[units: participants]
 		  55     55  
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)  
[units: ng*h/mL]
Mean ± Standard Deviation 		  2156.104  ± 1746.337     2130.082  ± 1486.442  


Statistical Analysis 1 for AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Ratio of the T/R geometric mean x 100 [3] 97.2
90% Confidence Interval ( 86.1 to 110 )
[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%.



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. ]

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
Test (Lansoprazole) 30 mg Lansoprazole DR Capsules test product dosed in either period.
Reference (Prevacid®) 30 mg Prevacid® DR Capsules reference product dosed in either period.

Measured Values
    Test (Lansoprazole)     Reference (Prevacid®)  
Number of Participants Analyzed  
[units: participants]
 		  55     55  
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)  
[units: ng*h/mL]
Mean ± Standard Deviation 		  2253.776  ± 2126.251     2195.918  ± 1667.722  


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] 97.4
90% Confidence Interval ( 86.3 to 110 )
[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:
unchecked 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.
unchecked 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.


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: NCT01045967     History of Changes
Other Study ID Numbers: B046530
Study First Received: January 8, 2010
Results First Received: February 22, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board