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Microsoft word - effect of modafinil on the pharmacokinetics of ethinyl estr

Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy
Clin Pharmacol Ther 2002 Jan;71(1):46-56 (ISSN: 0009-9236)
Robertson P; Hellriegel ET; Arora S; Nelson M
Department of Drug Disposition, Cephalon, Inc., West Chester, PA 19380, USA.
BACKGROUND: Modafinil has been reported to produce a concentration-related induction of
CYP3A4/5 activity in vitro in primary cultures of human hepatocytes. OBJECTIVE: Our
objective was to determine whether the pharmacokinetics of steady-state ethinyl estradiol (INN,
ethinylestradiol) and single-dose triazolam were altered after 4 weeks of modafinil treatment
in volunteers. METHODS: This was a placebo-controlled, single-blind, single-period study in
41 female subjects who were receiving long-term treatment with an oral contraceptive that
contained ethinyl estradiol (0.035 mg) and norgestimate (0.180-0.250 mg). Pharmacokinetic
profiles for ethinyl estradiol and for a single oral dose of triazolam (0.125 mg) were obtained
the day before initiation of treatment with modafinil (200 mg for 7 days, followed by 400 mg for
21 days) or placebo (28 days). A second dose of triazolam was administered with the final
dose of modafinil, and pharmacokinetic profiling was repeated. RESULTS: The modafinil
treatment group had a marked decrease in maximum observed plasma concentrations and
areas under the plasma concentration-time curve for triazolam relative to placebo, with a much
smaller decrease in these parameters for ethinyl estradiol. The half-life of triazolam was also
decreased, but the half-life of ethinyl estradiol did not appear to be affected by treatment with
modafinil. CONCLUSION: Modafinil induced CYP3A4/5 activity in humans in vivo, suggesting
that there is potential for metabolic drug-drug interactions between modafinil and substrates of
CYP3A4/5. However, the induction appeared to be more gastrointestinal than hepatic in nature.
Therefore significant metabolic drug-drug interactions are most likely to occur with compounds
(such as triazolam) that undergo significant gastrointestinal CYP3A4/5-mediated first-pass
CAS Registry / EC
Major Subject Heading(s)
Minor Subject Heading(s)
 Chromatography, High
 28911-01-5 (Triazolam)
 Half-Life
protein, human)
 Mixed Function Oxygenases  EC (nifedipine [metabolism]  Sedatives, Nonbarbiturate [adverse effects]  Single-Blind Method
 Spectrophotometry,
 Spectrum Analysis, Mass
Triazolam [adverse effects]



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Microsoft word - preliminary soma.doc

PRELIMINARY SUMMARY OF MAP ACTIONS To assist your community in maintaining the Flood Insurance Rate Map (FIRM), we have summarized below the previously issued Letter of Map Change (LOMC) actions (i.e., Letters of Map Revision (LOMRs) and Letters of Map Amendment (LOMAs)) that will be affected by the preparation of the enclosed revised FIRM panel(s). 1. LOMCs Incorporated The modification

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