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

A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health Male Volunteers

The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (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.

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