83565
document
Effect of simultaneous didanosine administration on itraconazole absorption in healthy volunteers . STUDY OBJECTIVE To investigate the effect of simultaneously administered didanosine ( ddI ) on the absorption of a single dose of itraconazole . DESIGN Randomized , crossover , unblinded single-dose pharmacokinetic study in healthy volunteers . Comparisons of itraconazole alone and itraconazole with simultaneous ddI were performed on days 1 and 15 . SETTING A university medical center . PATIENTS Seven healthy men and women . Six subjects ( 86 % ) completed the study ; one was removed due to the development of a rash . INTERVENTIONS Volunteers received a single 200-mg oral dose of itraconazole or itraconazole with concomitant oral ddI 300 mg ( two 150-mg tablets ) dispersed in 240 ml water . Each regimen was separated by a 2-week washout period . Serum samples were obtained frequently for 12 hours after the dose . MEASUREMENTS AND MAIN RESULTS Concentrations of itraconazole were determined using a microbiologic assay . Individual concentrations in serum versus time data were evaluated by linear regression analysis . Peak serum concentration and time to peak were determined by visual inspection of each individual 's serum concentration-time curve . A mean +/- SD peak serum itraconazole concentration of 0.90 +/- 0.30 micrograms/ml was observed at 3.0 +/- 0.7 hours when itraconazole was administered alone , compared with undetectable levels in all patients during therapy with ddI . CONCLUSIONS Simultaneous oral administration of ddI significantly decreases absorption of itraconazole . These drugs should not be administered concurrently .
83566
Intervention_Pharmacological
didanosine ( ddI
83567
Intervention_Pharmacological
itraconazole
83568
Intervention_Pharmacological
itraconazole alone
83569
Intervention_Pharmacological
itraconazole with simultaneous ddI
83570
Intervention_Pharmacological
single 200-mg oral dose of itraconazole
83571
Intervention_Pharmacological
itraconazole with concomitant oral ddI 300 mg ( two 150-mg tablets )
83572
Intervention_Pharmacological
itraconazole
83573
Intervention_Pharmacological
itraconazole
83574
Intervention_Pharmacological
oral administration of ddI
83575
Intervention_Pharmacological
itraconazole
83576
Outcome_Other
itraconazole absorption
83577
Outcome_Physical
serum versus time data
83578
Outcome_Other
Peak serum concentration
83579
Outcome_Other
time to peak
83580
Outcome_Other
mean +/- SD peak serum itraconazole concentration
83581
Outcome_Other
absorption of itraconazole
83582
Participant_Condition
healthy volunteers .
83583
Participant_Sample-size
Seven
83584
Participant_Sample-size
men
83585
Participant_Sample-size
women