Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

This study has been completed.

First Received: May 24, 2008 No Changes Posted

Sponsor:	Mutual Pharmaceutical Company, Inc.
Information provided by:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00685165

Purpose

The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline(primidone tablets) in adult subjects under fasting conditions.

Condition	Intervention	Phase
Therapeutic Equivalency	Drug: primidone	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet of Primidone 50mg, Compared to an Equivalent Dose of Mysoline in Healthy Adult Subjects

Resource links provided by NLM:

Drug Information available for: Primidone

U.S. FDA Resources

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	May 2004
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental One tablet containing 50mg of test product to be administered at hour 0 on Day 1 of each test period	Drug: primidone 50 mg tablet
B: Active Comparator One Mysoline tablet containing 50mg reference product to be administered at hour 0 on Day 1 of each test period	Drug: primidone 50 mg tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

male or female
at least 18 years of age
weight must be 15% of ideal weight for height and frame
subjects must be in good health and physical condition as determined by medical history
subjects must read and sign consent form

Exclusion Criteria:

history of treatment for alcoholism, substance abuse, or drug abuse within the last 24 months
history of malignancy, stroke, diabetes, cardiac, renal or liver disease
history of GERD, malabsorption syndrome, colon cancer, chronic colitis, including Crohn's disease
history of porphyria, hyperkinesia, respiratory diseases (eg. asthma, emphysema, difficulty breathing, pulmonary obstruction)
females who pregnant or lactating
history of hypersensitivity to primidone, barbiturates, and anticonvulsants
sitting systolic blood pressure below 90mm Hg, or diastolic pressure below 50mm Hg
heart rate less than 50 beats per minute after a 5 minute rest
treatment with any other investigation drug during the four weeks prior to initial dosing
subjects who have donated blood within four weeks prior to the initial dosing
subjects who smoke or use tobacco products or nicotine products. Three months abstinence is required.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

Daily Med - Posting of Recently Submitted Labeling to the FDA This link exits the ClinicalTrials.gov site

URL Pharma Generic Division This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D )
Study ID Numbers:	04090
Study First Received:	May 24, 2008
Last Updated:	May 24, 2008
ClinicalTrials.gov Identifier:	NCT00685165 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Primidone
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009