Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Age 19 - 45 years

• BMI 18.5 - 25.0 kg/m2

• Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening

Exclusion Criteria:

• Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives

• Subjects with a clinically relevant history of allergic reaction

• Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products

• At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results