Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00658541
First received: April 9, 2008
Last updated: April 29, 2011
Last verified: April 2011
Results First Received: December 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Healthy
Therapeutic Equivalency
Interventions: Drug: Zolpidem Tartrate 10 mg tablet
Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)

  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
Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.

Participant Flow for 3 periods

Period 1:   First Intervention
    Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets     Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets  
STARTED     19     19  
COMPLETED     19     19  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 7 Days
    Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets     Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets  
STARTED     19     19  
COMPLETED     18     17  
NOT COMPLETED     1     2  
Withdrawal by Subject                 1                 1  
Withdrawal by Subject                 0                 1  

Period 3:   Second Intervention
    Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets     Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets  
STARTED     18     17  
COMPLETED     18     17  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Baseline Measures
    Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.21  ± 11.45  
Gender  
[units: participants]
 
Female     9  
Male     29  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     31  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate   [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate   [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate   [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com


No publications provided


Responsible Party: Kristin Arnold, Vice President R&D, Mutual Pharmaceutical
ClinicalTrials.gov Identifier: NCT00658541     History of Changes
Other Study ID Numbers: 04065
Study First Received: April 9, 2008
Results First Received: December 16, 2009
Last Updated: April 29, 2011
Health Authority: United States: Institutional Review Board