Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03659305
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®
Sponsor:
R-Pharm
Organization:
Study Overview
Official Title:
Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2019-02
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 purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.
Detailed Description:
The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.
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?: