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Steady‐State Pharmacokinetics and Tolerability of Modafinil Administered Alone or in Combination with Dextroamphetamine in Healthy Volunteers
Author(s) -
Hellriegel Edward T.,
Arora Sanjay,
Nelson Michael,
Robertson Philmore
Publication year - 2002
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700222011382
Subject(s) - modafinil , tolerability , dextroamphetamine , pharmacokinetics , pharmacology , dosing , medicine , anesthesia , adverse effect , amphetamine , dopamine
The potential for a drug‐drug interaction between modafinil and dextroamphetamine, each at steady state, was investigated in an open‐label, randomized, single‐period study in 32 healthy male and female volunteers. All subjects received modafinil orally once daily for 28 days (200 mg on Days 1–7; 400 mg on Days 8–28). On Days 22 to 28, half of the subjects also received dextroamphetamine (20 mg) orally 7hours after modafinil. Samples for pharmacokinetic (PK) profiling were obtained on Days 21 and 28. The mean changes in PK parameters for modafinil and its two circulating metabolites between the two groups were not statistically significantly different, except C max for modafinil acid. Adverse events obtained in the two groups were similar and mild or moderate in nature. The results indicate that administration of low‐dose dextroamphetamine in this dosing regimen does not alterthe steady‐state pharmacokinetics of modafinil. The combination has a similar tolerability profile as modafinil alone.