Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Information source: Mutual Pharmaceutical Company, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency
Intervention: primidone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc.
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 subjects under fasting conditions.
Clinical Details
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
Study design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Recalls, Market Withdrawals and Safety Alerts Daily Med - Posting of Recently Submitted Labeling to the FDA URL Pharma Generic Division
Starting date: May 2004
Ending date: June 2004
Last updated: May 24, 2008
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