Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Primidone

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 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.