Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
Study NCT ID:
NCT04467203
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects
Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: