Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00939692
First received: July 13, 2009
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: July 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Healthy
Intervention: Drug: Topiramate

  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
Torrent's Topiramate First, Then Topamax

For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.

Followed by a 21 day washout period.

For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.

Topamax First, Then Torrent's Topiramate

For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.

Followed by a 21 day washout period.

For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.


Participant Flow for 2 periods

Period 1:   Period 1 - First Intervention - 5 Days
    Torrent's Topiramate First, Then Topamax     Topamax First, Then Torrent's Topiramate  
STARTED     13     13  
COMPLETED     12     13  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 2:   Period 2 - Second Intervent - 5 Days
    Torrent's Topiramate First, Then Topamax     Topamax First, Then Torrent's Topiramate  
STARTED     12     13  
COMPLETED     12     12  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  



  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
Torrent's Topiramate tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
Topamax tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
Total Total of all reporting groups

Baseline Measures
    Torrent's Topiramate     Topamax     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.3  ± 10.9     30.3  ± 10.9     30.3  ± 10.9  
Gender  
[units: participants]
     
Female     6     6     12  
Male     7     7     14  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]

3.  Primary:   The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]


  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: Walter A Parham
Organization: Gateway Medical Research, Inc.
phone: (314) 663-4550


No publications provided


Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00939692     History of Changes
Other Study ID Numbers: 06TOR01
Study First Received: July 13, 2009
Results First Received: July 22, 2009
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board