drugset / Trial / NCT02205320

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

NCT02205320

Phase 1 Unknown 192 enrolled Dr. Reddy's Laboratories Limited
RandomizedCrossoverDouble-blindTreatment

Summary

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

Timeline

Start
2014-02
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject DRL_PG Unknown 6 mg Subcutaneous
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

No indication recorded.