Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency
Intervention: Primidone 50 mg Tablet (Drug); Primidone (Mysoline®) 50 mg Tablet (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 Formulation of Primidone 50 mg, Compared to an Equivalent Dose of Primidone (Mysoline®) in Healthy Adult Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Maximum Plasma Concentration (Cmax)Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
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 subjects under fasting conditions.
Twenty-two healthy, non-smoking, non-obese male and female volunteers at least 18 years of
age will be randomly assigned in a crossover fashion to receive each of two primidone dosing
regimens in sequence with a 14 day washout period between dosing periods. On the morning of
Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single
oral dose of the test formulation, primidone (1 x 50 mg tablet) or a single oral dose of the
reference formulation, Mysoline® (1 x 50 mg tablet). After a 14 day washout period, on the
morning of Day 15 after an overnight fast, subjects will receive the alternate regimen.
Blood samples will be drawn from all participants before dosing and for 72 hours post dose
at times sufficient to adequately define the pharmacokinetics of primidone. A further goal
of this study is to evaluate the safety and tolerability of this regimen in healthy
volunteers. Subjects will be monitored throughout the confinement portion of the study for
adverse reactions to the study drugs and/or procedures. Blood pressure and heart rate will
be obtained prior to dosing and at 3, 4, 6, 24 and 72 hours post-dose. All adverse events
whether elicited by query, spontaneously reported or observed by clinic staff will be
evaluated by the investigator and reported in the subject's case report form.
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 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.
Locations and Contacts
Additional Information
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Starting date: May 2004
Last updated: December 16, 2009
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