Status:
COMPLETED
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Therapeutic Equivalency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 sub...
Detailed Description
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 su...
Eligibility Criteria
Inclusion
- 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
- 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 gastroesophageal reflux disease (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 (conditions upon screening which might contraindicate or require that caution be used in the administration of primidone)
- heart rate less than 50 beats per minute after a 5 minute rest
- treatment with any other investigational 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00685165
Start Date
May 1 2004
End Date
June 1 2004
Last Update
January 20 2010
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