Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Phase I PK Study of BalcinrenoneDapagliflozin in Healthy Chinese Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label Study to Assess the Pharmacokinetics Safety and Tolerability Following Administration of a Single Dose of BalcinrenoneDapagliflozin in Healthy Chinese Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to evaluate the PK safety and tolerability of balcinrenonedapagliflozin given as a single dose capsule to healthy Chinese participants
Detailed Description:
This is a Phase I open-label single-arm single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China In this study approximately 10 participants both females and males will be assigned to the IMP Each participant will receive a single dose of a capsule with balcinrenonedapagliflozin 40 mg10 mg on Day 1 under fasted condition The study will comprise of the following
A screening period
A treatment period
A follow-up visit At the discretion of the investigator the participant may remain in the study center until the completion of the follow-up visit
A screening period
A treatment period
A follow-up visit At the discretion of the investigator the participant may remain in the study center until the completion of the follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None