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Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01684605
First received: September 11, 2012
Last updated: May 22, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after IV administration in health male volunteers

Condition Intervention Phase
Anemia Drug: NESP 60μg Drug: CKD-11101 60μg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After IV Administration in Health Male Volunteers

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Assess AUClast of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]
  • Assess Cmax of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]

Secondary Outcome Measures:
  • Assess AUCinf of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]
  • Assess Tmax of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]
  • Assess t1/2 of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]
  • Assess CL of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ]

Enrollment: 31
Actual Study Start Date: October 12, 2012
Study Completion Date: January 3, 2013
Primary Completion Date: November 13, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NESP 60μg
Prefilled syringe filled with Darbepoetin alfa 60μg
Drug: NESP 60μg
Administrated NESP 60μg once intravenously
Experimental: CKD-11101 60μg
Prefilled syringe filled with Darbepoetin alfa 60μg
Drug: CKD-11101 60μg
Administrated CKD-11101 60μg once intravenously

Detailed Description:
Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.
  Eligibility

Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed the informed consent form prior to study participation.
  • A healthy male volunteer between 20 and 55 years old.
  • Body weight between 55kg and 90kg, BMI between 18 and 27.
  • Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)

Exclusion Criteria:

  • Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
  • Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
  • Have abnormal laboratory result.

    • Hemoglobin < 12g/dL or > 17g/dL
    • Vitamin B12 < 200pg/mL
    • Ferritin < 21.8ng/mL
    • Transferrin < 190mg/dL
    • Reticulocyte over the normal limit
    • Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
    • Positive for HIV antibody, HBsAg, HCV antibody test
  • A heavy smoker (cigarette > 10 cigarettes per day)
  • Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
  • Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
  • sit SBP < 90mmHg or sit SBP > 140mmHg or sit DBP < 55mmHg or sit DBP > 90mmHg or Pulse rate > 100 per/min
  • History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
  • Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
  • Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
  • A heavy alcohol consumer (alcohol > 21 units/week) or cannot stop drinking
  • Bleed or donate blood (> 400mL) within 8 weeks before the first IP administration
  • Participated in this clinical trials and administrated IP
  • Have a diet within 2 days before the first IP administration or cannot stop having

    • food containing grapefruit
    • food containing caffeine
  • Disagree to avoid getting pregnant during clinical trial
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684605

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Seoul National University Hospital
Investigators
Principal Investigator: Kyung Sang Yu, Ph.D Seoul National University Hospital
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01684605     History of Changes
Other Study ID Numbers: 136HPS12D
Study First Received: September 11, 2012
Last Updated: May 22, 2017

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-11101
NESP
Darbepoetin alfa
Anemia
intravenous
Pharmacokinetics
Phase 1

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on June 23, 2017