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Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01157182
First received: July 2, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
Results First Received: September 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Estradiol/Norethindrone acetate
Drug: Activella®

  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
Estradiol/Norethindrone Acetate (Test) First 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
Activella® (Reference) First 1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Estradiol/Norethindrone Acetate (Test) First     Activella® (Reference) First  
STARTED     18     18  
COMPLETED     18     18  
NOT COMPLETED     0     0  

Period 2:   Washout of 28 Days
    Estradiol/Norethindrone Acetate (Test) First     Activella® (Reference) First  
STARTED     18     18  
COMPLETED     16     18  
NOT COMPLETED     2     0  
Adverse Event                 2                 0  

Period 3:   Second Intervention
    Estradiol/Norethindrone Acetate (Test) First     Activella® (Reference) First  
STARTED     16     18  
COMPLETED     16     18  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Estradiol/Norethindrone Acetate (Test) First 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
Activella® (Reference) First 1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
    Estradiol/Norethindrone Acetate (Test) First     Activella® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  18     18     36  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     17     18     35  
>=65 years     1     0     1  
Gender  
[units: participants]
 		     
Female     18     18     36  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     12     14     26  
Hispanic     0     3     3  
Black     3     0     3  
Asian     3     0     3  
American Indian     0     1     1  
Region of Enrollment  
[units: participants]
 		     
Canada     18     18     36  



  Outcome Measures
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1.  Primary:   Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 36 hour period. ]
  Show Outcome Measure 1

2.  Primary:   AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 36 hour period. ]
  Show Outcome Measure 2

3.  Primary:   AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 36 hour period. ]
  Show Outcome Measure 3

4.  Primary:   Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 4

5.  Primary:   AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 5

6.  Primary:   AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 6

7.  Secondary:   Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 7

8.  Secondary:   AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 8

9.  Secondary:   AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 9

10.  Secondary:   Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 10

11.  Secondary:   AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 11

12.  Secondary:   AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 12

13.  Secondary:   Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 13

14.  Secondary:   AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 14

15.  Secondary:   AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 15

16.  Secondary:   Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 16

17.  Secondary:   AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 17

18.  Secondary:   AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 18

19.  Secondary:   Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 19

20.  Secondary:   AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 20

21.  Secondary:   AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)   [ Time Frame: Blood samples collected over a 72 hour period. ]
  Show Outcome Measure 21


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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