Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829309
First received: January 26, 2009
Last updated: September 9, 2009
Last verified: September 2009
Results First Received: July 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Intervention: Drug: Pravastatin

  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
Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period

Participant Flow for 3 periods

Period 1:   First Intervention
    Pravastatin (Test) First     Pravachol® (Reference) First  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 2:   Washout: 7 Days
    Pravastatin (Test) First     Pravachol® (Reference) First  
STARTED     8     8  
COMPLETED     7     8  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  

Period 3:   Second Intervention
    Pravastatin (Test) First     Pravachol® (Reference) First  
STARTED     7     8  
COMPLETED     7     8  
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
Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
Total Total of all reporting groups

Baseline Measures
    Pravastatin (Test) First     Pravachol® (Reference) First     Total  
Number of Participants  
[units: participants]
  8     8     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     8     16  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     8     16  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     8     6     14  
Hispanic     0     1     1  
Black     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     8     8     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax - Maximum Observed Concentration - Pravastatin in Plasma   [ Time Frame: Blood samples collected over 16 hour period ]

2.  Primary:   AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 16 hour period ]

3.  Primary:   AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)   [ Time Frame: Blood samples collected over 16 hour period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information