Therapeutic Equivalency Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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