- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959777
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
September 29, 2014 updated by: Dong-A ST Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yonggon-Dong, Chongono-Gu
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Seoul, Yonggon-Dong, Chongono-Gu, Korea, Republic of, 110-744
- Clinical Trials center, Clinical Research institute, Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DA-3031
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Active Comparator: filgrastim
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 13, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA3031_NP_I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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