Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00939367
First received: July 13, 2009
Last updated: October 22, 2013
Last verified: October 2013
Results First Received: July 22, 2009  
Study Type: Interventional
Condition: Healthy
Interventions: Drug: Zolpidem Tartrate Tablets 10 mg
Drug: 'Sanofi-Synthelabo's Ambien® 10 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
healthy, normal subjects

Reporting Groups
  Description
Torrent's Zolpidem First, Then Ambien

For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.

Followed by a 7 day washout period.

For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg.

Ambien First, Then Torrent's Zolpidem

For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg

Followed by a 7 day washout period.

For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg.


Participant Flow for 2 periods

Period 1:   First Intervention
    Torrent's Zolpidem First, Then Ambien     Ambien First, Then Torrent's Zolpidem  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  

Period 2:   Second Intervention
    Torrent's Zolpidem First, Then Ambien     Ambien First, Then Torrent's Zolpidem  
STARTED     15     15  
COMPLETED     15     15  
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.
No text entered.

Reporting Groups
  Description
All Study Participants Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.6  ± 7.48  
Gender  
[units: participants]
 
Female     11  
Male     19  
Region of Enrollment  
[units: participants]
 
India     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]

3.  Primary:   The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)   [ Time Frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose. ]


  Serious Adverse Events


  Other Adverse Events


  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: Kedar Joshi
Organization: Accutest Research Laboratories Pvt. Ltd.
phone: +91 22 27780718


No publications provided


Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00939367     History of Changes
Other Study ID Numbers: US/05/004
Study First Received: July 13, 2009
Results First Received: July 22, 2009
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board
India: Institutional Review Board