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

• Status: Completed
• Trial end date: 2013-01-03
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Collaborator: Seoul National University Hospital
• Treatments: Darbepoetin alfa

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