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

History of Changes

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
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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
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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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. ]

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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. ]

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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. ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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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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

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