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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829309
First Posted: January 27, 2009
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceuticals USA
Results First Submitted: July 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Intervention: Drug: Pravastatin

  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
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
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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
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 
Overall Participants Analyzed 
[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
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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