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

Date de début de l'étude : 12 octobre 2012

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