Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-20 @ 12:31 PM
Study NCT ID:
NCT02991261
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2016-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
Sponsor:
Sun Pharma Advanced Research Company Limited
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
Status:
COMPLETED
Status Verified Date:
2019-05
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:
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: