Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT03751969
Status:
WITHDRAWN
Last Update Posted:
2022-06-02
First Post:
2018-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Organization:
Study Overview
Official Title:
A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study canceled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous \[14C\]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug.
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?: