Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers
Abstract
BACKGROUND: "Udenafil" is a phosphodiesterase-5 inhibitor indicated for erectile dysfunction. "Dapoxetine" is a serotonin transport inhibitor indicated for premature ejaculation. The aim of the study reported here was to investigate the pharmacokinetic drug interaction between udenafil and dapoxetine in healthy male subjects.
METHODS: An open-label, three-treatment, six-sequence, three-period crossover study was performed in healthy male subjects. In varying sequences, each subjects received single oral doses of udenafil 200 mg, dapoxetine 60 mg, and both treatments. The periods were separated by a washout period of 7 days. Serial blood samples were collected up to 48 hours after dosing. The plasma concentrations of udenafil and dapoxetine were determined using a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were obtained by non-compartmental analysis. Tolerability was assessed throughout the study.
RESULTS: Twenty-three healthy subjects completed the study. The geometric mean ratios of the area under the plasma concentration-time curve from time 0 to last measurable time point and measured peak plasma concentration for udenafil were 0.923 (90% confidence interval [CI]: 0.863-0.987) and 0.864 (90% CI: 0.789-0.947), respectively. The geometric mean ratios of the area under the plasma concentration-time curve from time 0 to last measurable time point and measured peak plasma concentration for dapoxetine were 1.125 (90% CI:…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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