Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439530
Status:
COMPLETED
Last Update Posted:
2009-07-28
First Post:
2007-02-21
Brief Title:
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2006-11
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:
SEA002
Brief Summary:
Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit Faculty of Tropical Medicine and commenced enrolling healthy volunteers on 23 November 2006 The duration of the study is expected to be approximately four months The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SEA ICRN | None | None | None |