Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218616
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2022-01-20
Brief Title:
The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions
Sponsor:
JLLC NatiVita
Organization:
JLLC NatiVita
Study Overview
Official Title:
Single-dose Open-label 2 Periods 2 Sequences Randomized Crossover Bioequivalence Study of Aviga 50 mg Capsules JLLC NATIVITA Belarus and Sutent 50 mg Capsules Pfizer Italia SRL in Healthy Volunteers Under Fasting Conditions
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
NOT_YET_RECRUITING
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 study is designed in accordance with the Eurasian Economic Union EAEU regulatory guidelines with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers Within the clinical portion of the study each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None