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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: June 2004

Intervention(s) in this Clinical Trial

• Drug: primidone
  • 50 mg tablet
• Drug: primidone
  • 50 mg tablet

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Bioequivalence
  • Time Frame: Two Weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685165

Study ID Number: 04090

ClinicalTrials.gov Identifier: NCT00685165

Health Authority: United States: Institutional Review Board

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

URL Pharma Generic Division