Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-08
Brief Title:
An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects
Sponsor:
Zhuhai Beihai Biotech Co Ltd
Organization:
Zhuhai Beihai Biotech Co Ltd
Study Overview
Official Title:
An Open-label Randomized Single-dose Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The study is an open label randomized balanced two period two sequence crossover single dose relative bioavailability study in healthy subjectsEach subject meeting all the inclusion criteria and none of the exclusion criteria will receive test product or reference product in a crossover manner based on randomization schedule A balance between T-R and R-T randomization sequence will be ensured using statistical techniques Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 Period I Day 15 Period II
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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