Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-17 @ 10:04 PM
Study NCT ID:
NCT03751956
Status:
COMPLETED
Last Update Posted:
2019-10-28
First Post:
2018-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Mass Balance of [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 and Biotransformation of [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults.
Status:
COMPLETED
Status Verified Date:
2019-10
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 study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of \[14C\]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.
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?: