The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects. Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a single center, randomized, open-label, two-period crossover study in approximately 14 Chinese healthy adult male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Seven subjects in group A will receive treatment in the following order: At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-\> At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order: At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-\> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
Haiyan Li
Beijing, Beijing Municipality, China
Pharmacokinetic Parameter AUC(0-24)
AUC(0-24) of Fadanafile is area usder the curve
Time frame: Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours
Electrocardiogram (ECG) QT interval Safety and tolerability
To evaluate subject ECG QT interval Changing information
Time frame: Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours
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