Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387966
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-06
Brief Title:
A Randomized Double-blindDose-escalating Single-dose Oral Phase I Clinical Study of Flunotinib Healthy People
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Dose-escalating Single-dose Oral Phase I Clinical Study of the Safety Tolerability and Pharmacokinetics of Flunotinib Maleate Tablets in Healthy Adult Subjects in China
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets
Detailed Description:
The goal of this clinical trial is to evaluate the safety of sflunotinib maleate tablets The main questions it aims to answer are
1 The safety and tolerability of single oral doses of flunotinib maleate tablets in escalating doses in healthy adult subjects in China
2 The pharmacokinetic characteristics of a single dose of oral flunotinib maleate tablets Participants will divide into experimental group and placebo group conduct single oral administration safety and tolerability test group by group
1 The safety and tolerability of single oral doses of flunotinib maleate tablets in escalating doses in healthy adult subjects in China
2 The pharmacokinetic characteristics of a single dose of oral flunotinib maleate tablets Participants will divide into experimental group and placebo group conduct single oral administration safety and tolerability test group by group
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?:
None