Overview

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

Status:
Completed
Trial end date:
2013-01-15
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC 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