Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-30 @ 10:05 PM
Study NCT ID:
NCT03959332
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Phase I, Single-Centre, Open-Label, Parallel, Two Dose Level Study to Investigate the Pharmacokinetics, Safety, and Tolerability Following a Single Dose of Baloxavir Marboxil in Healthy Chinese Volunteers
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 study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
Detailed Description:
None
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?: