Comparison of the Single‐Dose Pharmacokinetics and Tolerability of Modafinil and Dextroamphetamine Administered Alone or in Combination in Healthy Male Volunteers

Abstract

An open-label, randomized, crossover study was performed in healthy male volunteers to evaluate the potential pharmacokinetic and pharmacodynamic interactions and tolerability of single oral doses of modafinil (200 mg) and dextroamphetamine (10 mg). Blood samples were collected for determination of plasma levels of modafinil, the acid and sulfone metabolites of modafinil, and dextroamphetamine at intervals through 48 hours after administration for each treatment. Vital signs (blood pressure and pulse rate) were measured through 48 hours, and electrocardiograms were measured through 24 hours after administration. Pharmacokinetic parameters were determined using noncompartmental methods. The data collected in this study of 24 healthy volunteers suggest that concomitant administration of single oral doses of modafinil and dextroamphetamine has no clinically significant effects on the pharmacokinetic profile of either agent. Although there was a slightly greater incidence of adverse events when modafinil and dextroamphetamine were administered together, the concomitant administration of the two drugs was well tolerated.

Smoked Cocaine Self-Administration is Decreased by Modafinil

“…Modafinil has a relatively benign side-effect profile and no clinically significant drug interactions (Wong et al, 1998;Hellriegel et al, 2001). Data from the current investigation are consistent with previous findings.…”

Pharmacokinetic Study of Modafinil in Relation to Gender and Ethnicity in Healthy Young Chinese Volunteers

“…The results of pharmacokinetic parameters are consistent with those reported by others (24)(25)(26) and could be served as the basic of the evaluation for the influence of ethnicity and sex.…”

Modafinil Elicits Sympathomedullary Activation

“…These effects have been underestimated in the literature. Studies that conclude that use of modafinil in clinical conditions has minimal or absent autonomic cardiovascular activation [23][24][25][26] were generally not undertaken under optimal control conditions (abstinence of concurrent drugs, caffeine, alcohol, and nicotine, strict dietary sodium and potassium balance, and hospitalization to ensure control of food intake and physical activity). Results are meansϮSEM.…”