Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04135820
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
Sponsor:
Beta Pharma, Inc.
Organization:
Study Overview
Official Title:
An Open-label, Randomised, Single Dose, Cross-over Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
Status:
COMPLETED
Status Verified Date:
2020-07
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 an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
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?: