Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592300
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy Adult Human Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Balanced Randomized Two-sequence Two-treatment Four -Period Single Oral Dose Fully ReplicateBioequivalence Study in Normal Healthy Adult Human Subjects Under Fed Condition
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsors test product relative to that of reference product after single oral dose fully replicate bioequivalence study in normal healthy adult human subjects under fed condition
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