Completed PHASE1 INTERVENTIONAL 2-arm NCT03146988

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

Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects

Sponsor: Gedeon Richter Plc.

Conditions Bioequivalence

Interventions RGB-02 or Neulasta® (pegfilgrastim)

Updated 7 times since 2017 Last updated: Nov 21, 2017 Started: Apr 10, 2017 Primary completion: Sep 14, 2017 Completion: Oct 4, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Bioequivalence and is currently completed. Gedeon Richter Plc. leads this study, which shows 7 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Dec 2017 — Jun 2018 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed

▶ Show 2 earlier versions

Sep 2017 — Dec 2017 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Jun 2017 — Sep 2017 [monthly]

Recruiting PHASE1

First recorded

Apr 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Gedeon Richter Plc.

Data source: Gedeon Richter Plc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Ruddington, United Kingdom