Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00684723
First received: May 24, 2008
Last updated: January 11, 2010
Last verified: January 2010
Results First Received: November 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Healthy
Interventions: Drug: Lovastatin 40 mg Tablets
Drug: Lovastatin (Mevacor®) 40 mg Tablets

  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
Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.

Participant Flow for 3 periods

Period 1:   First Intervention
    Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets     Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets  
STARTED     27     27  
COMPLETED     27     27  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 7 Days
    Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets     Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets  
STARTED     27     27  
COMPLETED     27     27  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets     Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets  
STARTED     27     27  
COMPLETED     27     27  
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
Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.

Baseline Measures
    Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets  
Number of Participants  
[units: participants]
  54  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     54  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 10  
Gender  
[units: participants]
 
Female     0  
Male     54  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     52  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. ]

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com


No publications provided


Responsible Party: Kristin Arnold, Vice President R&D, Mutual Pharmaceutical
ClinicalTrials.gov Identifier: NCT00684723     History of Changes
Other Study ID Numbers: LVI-P4-126
Study First Received: May 24, 2008
Results First Received: November 24, 2009
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board