Trials Sponsors Conditions Drugs Pricing

Conditions

Leucocytosis

Keywords

neutrophil countfilgrastimgranulocyte colony-stimulating factor

Outcome Measures

Primary Outcomes (2)

AUC (0-48 Hours)
Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
0 to 48 hours post-dose
Cmax After Subcutaneous Injection
Maximal concentration of filgrastim after subcutaneous injection of filgrastim
0 to 48 hours post-dose

Secondary Outcomes (15)

Cmax After Intravenous Injection
0 to 48 hours post-dose
Tmax After Injection
0 to 48 hours post-dose
Т½
0 to 48 hours post-dose
Kel
0 to 48 hours post-dose
Clearance
0 to 48 hours post-dose
+10 more secondary outcomes

Study Arms (4)

Leucostim® --> Neupogen®, subcutaneous injections

EXPERIMENTAL

Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

Biological: Leucostim®Biological: Neupogen®

Neupogen® --> Leucostim®, subcutaneous injections

EXPERIMENTAL

Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

Biological: Leucostim®Biological: Neupogen®

Leucostim® --> Neupogen®, intravenous injections

EXPERIMENTAL

Interventions

Leucostim®Biological

Leucostim® is filgrastim biosimilar.

Also known as: filgrastim

Leucostim® --> Neupogen®, intravenous injectionsLeucostim® --> Neupogen®, subcutaneous injectionsNeupogen® --> Leucostim®, intravenous injectionsNeupogen® --> Leucostim®, subcutaneous injections

Neupogen®Biological

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Written informed consent.
Male gender.

Sponsors & Collaborators

Biocad
Industrylead

MeSH Terms

Conditions

Leukocytosis

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Leukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydrates

Results Point of Contact

Title: Yulia Linkova Medical Director
Organization: Biocad

Study Officials

Roman Ivanov, PhD
JCS BIOCAD
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

May 5, 2016

Study Start

July 18, 2016

Actual (reported)

Primary Completion

Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Study Arms (4)

Leucostim® --> Neupogen®, subcutaneous injections

Neupogen® --> Leucostim®, subcutaneous injections

Leucostim® --> Neupogen®, intravenous injections

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Neupogen® --> Leucostim®, intravenous injections

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Study Arms (4)

Leucostim® --> Neupogen®, subcutaneous injections

Neupogen® --> Leucostim®, subcutaneous injections

Leucostim® --> Neupogen®, intravenous injections

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Neupogen® --> Leucostim®, intravenous injections

You may not qualify if:

Source record