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

NCT04467203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-07-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467203 on ClinicalTrials.gov