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NCT00959777 Clinical Trial

Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00959777
Other study ID # DA3031_NP_I
Secondary ID
Status Completed
Phase Phase 1
First received August 13, 2009
Last updated September 29, 2014

Study information
Verified date September 2014
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy males subjects, 20-40 years inclusive

- weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive

- Written informed consent given

- Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

- Hypersensitivity to drugs(aspirin, antibiotics and so on)

- History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology

- Have a history of drug abuse, or show positive for drug abuse at urine screening

- Have participated in another clinical study within 2 months prior to entering inth the study

- Have been persistently drinking alcohol or can not stop drinking alcohol during the study

- Smokers whose average smoke for last 3 months is more than 10 cigarettes/day

- Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• DA-3031

• Filgrastim

Locations
Country Name City State
Korea, Republic of Clinical Trials center, Clinical Research institute, Seoul National University Hospital Seoul Yonggon-Dong, Chongono-Gu

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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