None listed
Conditions
Brief summary
To assess the capacity of a vigilance promoting agent (modafinil) to ‘perpetrate’ metabolic drug interactions that may lead to adverse effects.
Interventions
Simultaenous administration of single doses of five drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg) on three occasions on study days 0,1 and 7. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of modafinil 200mg daily for seven days on study Days 1 to 7. The modafinil will be given as tablets with water. A single modafinil plasm
Simultaenous administration of single doses of five drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg) on three occasions on study days 0,1 and 7. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of modafinil 200mg daily for seven days on study Days 1 to 7. The modafinil will be given as tablets with water. A single modafinil plasma concentration will be measured post-dose on Day 7 to monitor adherence and to ensure steady-state has been achieved.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Aged 18 - 40
Exclusion criteria
taking medications significant health conditions unable to comply with study requirements
Outcome results
None listed