Simultaneous administration of vardenafil and alcohol does not result in a pharmacodynamic or pharmacokinetic interaction in healthy male subjects.
OBJECTIVE
To investigate the pharmacodynamic effects of the combined administration of vardenafil and ethanol on blood pressure and heart rate and to study the mutual pharmacokinetic interaction, safety and tolerability of the combination.


METHODS
12 healthy male subjects aged 18 - 45 years received 3 different single-dose treatments in a randomized, double-blind, placebo-controlled crossover design: 20 mg vardenafil plus 0.5 g/kg ethanol, vardenafil plus placebo and ethanol plus placebo. Heart rate (HR) as well as systolic (SBP) and diastolic blood pressure (DBP) were measured in supine position after 15 min of rest at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 and 24 h post dosing using a validated oscillometric sphygmomanometer. Vardenafil, vardenafil metabolite M-1 and ethanol pharmacokinetics were assessed.


RESULTS
There were no statistically significant differences between treatments in DBP and SBP. Significantly higher increases in HR were seen when the combination vardenafil/ethanol and ethanol/placebo treatment, respectively, was compared with vardenafil/placebo treatment. The difference between the 2 treatments including ethanol, however, was not significant. All hemodynamic changes were not clinically relevant. The pharmacokinetics of vardenafil and ethanol were not changed in the treatment "vardenafil + ethanol" compared to the respective treatment with vardenafil and ethanol alone. The most frequently reported adverse events were vasodilation and nasal congestion, well-known side effects of PDE-5 inhibitors such as vardenafil.


CONCLUSIONS
Concomitant administration of vardenafil and alcohol was well-tolerated. No clinically relevant pharmacodynamic or pharmacokinetic interactions were detected.
Wensing
G
G
Institute of Clinical Pharmacology, Bayer HealthCare AG, Wuppertal, Germany. georg.wensing@bayerhealthcare.com
Bauer
R
R
Unger
S
S
Rohde
G
G
Heinig
R
R
D000284:Administration, Oral; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000493:pharmacokinetics*; D004347:Drug Interactions; D000431:Ethanol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D010879:Piperazines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013450:Sulfones / Q000008:administration & dosage / Q000493:pharmacokinetics; D014227:Triazines / Q000008:administration & dosage / Q000493:pharmacokinetics; D000069058:Vardenafil Dihydrochloride
D002492:Central Nervous System Depressants; D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000431:Ethanol; D000069058:Vardenafil Dihydrochloride