A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects - LA-EP2006 Bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43539

Enrollment

184

Registered

2015-12-10

Start date

2016-02-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infection reduced white blood cell count

Interventions

The study will consist of 2 periods. You will receive one single injection of 6 mg LA-EP2006 diluted in 0.6 mL solution during one period and one single injection of 6 mg Neulasta® diluted in 0.6 mL

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male and female volunteers - age 18 - 45 inclusive - BMI between 19.0 and 28.0 kilograms/meter2 - weight >

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 12 weeks from the start of the study.

Design outcomes

Primary

Measure	Time frame
To determine bioequivalence of LA-EP2006 and Neulasta® EU following a single 6 mg subcutaneous (s.c.) injection in terms of the pegfilgrastim pharmacokinetic parameters AUC0** and Cmax.	—

Secondary

Measure	Time frame
Secondary objectives are to further compare LA-EP2006 and Neulasta® EU with respect to: * Pharmacokinetic parameters AUC0last, tmax, and t * Absolute neutrophil count (ANC) response as assessed by AUEC(0-336h), Emax, tmax,E * Safety, immunogenicity, and local tolerance	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)