NCT02205320

A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
BIOLOGICAL	DRL_PG
BIOLOGICAL	Pegfilgrastim Form A
BIOLOGICAL	Pegfilgrastim Form B

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-07-31
• Last updated: 2014-07-31

Locations

1 site across 1 country: United States