Trials / Completed
CompletedNCT02762799
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Single-center Open Randomized Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® (JSC "BIOCAD", Russia) Compared to Neupogen® (F. Hoffman-La Roche Ltd., Switzerland)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Biocad · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Leucostim® | Leucostim® is filgrastim biosimilar. |
| BIOLOGICAL | Neupogen® |
Timeline
- Start date
- 2016-07-18
- Primary completion
- 2016-11-11
- Completion
- 2016-11-11
- First posted
- 2016-05-05
- Last updated
- 2018-12-19
- Results posted
- 2018-12-19
Source: ClinicalTrials.gov record NCT02762799. Inclusion in this directory is not an endorsement.