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
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
  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
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
  Hide Baseline Characteristics

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
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
  Show All Outcome Measures

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

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information