# Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®

> **NCT01933971** · PHASE1 · COMPLETED · sponsor: **Bio-ker S.r.l.** · enrollment: 102 (actual)

## Conditions studied

- Healthy Male Subjects

## Interventions

- **DRUG:** Filgrastim test
- **DRUG:** Filgrastim reference

## Key facts

- **NCT ID:** NCT01933971
- **Lead sponsor:** Bio-ker S.r.l.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-06
- **Primary completion:** 2008-04
- **Final completion:** 2008-04
- **Target enrollment:** 102 (ACTUAL)
- **Last updated:** 2013-09-09

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01933971

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01933971, "Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01933971. Licensed CC0.

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