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Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

NCT03146988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-11-22

No results posted yet for this study

Summary

Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.

Conditions

  • Bioequivalence

Interventions

DRUG

RGB-02 or Neulasta® (pegfilgrastim)

Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area

Sponsors & Collaborators

  • Gedeon Richter Plc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2017-09-14
Completion
2017-10-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146988 on ClinicalTrials.gov