NCT04467203

Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects

A Single Center, Randomized, Open-label, Two-period Crossover Phase 1b Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Oral Fadanafil Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fadanafil	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

Timeline

• Start date: 2019-04-28
• Primary completion: 2019-05-14
• Completion: 2019-06-28
• First posted: 2020-07-10
• Last updated: 2020-07-10

Locations

1 site across 1 country: China