Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta) in Healthy Volunteers
Phase of Trial: Phase I
Latest Information Update: 11 Oct 2016
At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Autoimmune disorders; Cancer
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Mylan
- 11 Oct 2016 Primary endpoint (Maximum Serum Concentration (Cmax) of pegfilgrastim) has been met.
- 11 Oct 2016 Primary endpoint (Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim) has been met.
- 11 Oct 2016 Primary endpoint (Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax) has been met.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History