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Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor

2014-08-27 03:19:37 | BioPortfolio

Summary

This study is a four arm, parallel study.

Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).

Description

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9, Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Healthy

Intervention

GCPGC, Neulasta, Placebo

Location

Clinical Trials Center, Seoul National University Hospital
Seoul
Korea, Republic of
110-744

Status

Recruiting

Source

Seoul National University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:37-0400

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