Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
Study NCT ID:
NCT03776968
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2018-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics
Sponsor:
Hinova Pharmaceuticals Inc.
Organization:
Study Overview
Official Title:
A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics in Healthy Chinese Adults
Status:
COMPLETED
Status Verified Date:
2020-10
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:
This is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in healthy Chinese males, subsequent to a single oral administration of HC-1119 with different doses in healthy Chinese males.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: