Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

This study has been completed.

Study NCT00685165 Information provided by Mutual Pharmaceutical Company, Inc.

First Received on May 24, 2008. Last Updated on December 16, 2009 History of Changes

Results First Received: November 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Therapeutic Equivalency
Interventions:	Drug: Primidone 50 mg Tablet Drug: Primidone (Mysoline®) 50 mg Tablet

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
Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets	On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets	On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.

Participant Flow for 3 periods

Period 1: First Intervention

	Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets	Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Period 2: Washout Period of 14 Days

	Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets	Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets
STARTED	11	11
COMPLETED	10 ^[1]	11
NOT COMPLETED	1	0
Adverse Event	1	0

[1]	adverse event- possible upper respiratory infection

Period 3: Second Intervention

	Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets	Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Primidone 50 mg Tablets and Mysoline® 50 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 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.

Baseline Measures

	Primidone 50 mg Tablets and Mysoline® 50 mg Tablets
Number of Participants [units: participants]	22
Age [units: participants]
<=18 years	0
Between 18 and 65 years	22
>=65 years	0
Age [units: years] Mean ± Standard Deviation	31.76 ± 12.10
Gender [units: participants]
Female	9
Male	13
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	1
Not Hispanic or Latino	21
Unknown or Not Reported	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	9
White	10
More than one race	0
Unknown or Not Reported	3

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, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 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, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 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, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 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 Company, Inc.
ClinicalTrials.gov Identifier:	NCT00685165 History of Changes
Other Study ID Numbers:	04090
Study First Received:	May 24, 2008
Results First Received:	November 18, 2009
Last Updated:	December 16, 2009
Health Authority:	United States: Institutional Review Board