Text Size

Glimepiride 4 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834340
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
Results First Received: June 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Glimepiride 4 mg Tablets
Drug: AMARYL® 4 mg Tablets

  Participant Flow
  Hide Participant Flow

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
Glimepiride (Test) First Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
Amaryl® (Reference) First Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

 Period 1:   First Intervention
    Glimepiride (Test) First     Amaryl® (Reference) First  
STARTED     16     16  
COMPLETED     16     16  
NOT COMPLETED     0     0  

Period 2:   Washout
    Glimepiride (Test) First     Amaryl® (Reference) First  
STARTED     16     16  
COMPLETED     14     16  
NOT COMPLETED     2     0  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  

Period 3:   Second Intervention
    Glimepiride (Test) First     Amaryl® (Reference) First  
STARTED     14     16  
COMPLETED     14     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Glimepiride (Test) First Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
Amaryl® (Reference) First Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
    Glimepiride (Test) First     Amaryl® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  16     16     32  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     4     5     9  
Male     12     11     23  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Caucasian     3     0     3  
Black     4     8     12  
Hispanic     8     8     16  
Biracial     1     0     1  
Region of Enrollment  
[units: participants]
 		     
United States     16     16     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax - Maximum Observed Concentration   [ Time Frame: Blood samples collected over 24 hour period ]
  Show Outcome Measure 1

2.  Primary:   AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 24 hour period ]
  Show Outcome Measure 2

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration   [ Time Frame: Blood samples collected over 24 hour period ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information