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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959777
First Posted: August 17, 2009
Last Update Posted: October 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dong-A ST Co., Ltd.
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Drug: DA-3031 Drug: Filgrastim Phase 1

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Arms Assigned Interventions
Experimental: DA-3031 Drug: DA-3031
Active Comparator: filgrastim Drug: Filgrastim

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959777


Locations
Korea, Republic of
Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00959777     History of Changes
Other Study ID Numbers: DA3031_NP_I
First Submitted: August 13, 2009
First Posted: August 17, 2009
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs