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drugset / Trial / NCT04467203

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

NCT04467203 ↗

Phase 1 Completed 14 enrolled Sihuan Pharmaceutical Holdings Group Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2019-04-28
Primary completion
2019-05-14
Completion
2019-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Fadanafil Unknown 100 mg Oral

Indications

No indication recorded.