Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-29 @ 10:00 PM
Study NCT ID:
NCT05070195
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of SKLB1028 on the Pharmacokinetics of Midazolam in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-09
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 single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.
Detailed Description:
This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with the sensitive index substrate drug (Midazolam) in Healthy Subjects. The study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
Study Oversight
Has Oversight DMC:
False
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?: