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

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Anemia

Treatments

Drug: NESP 60μg

Drug: CKD-11101 60μg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01685671

136HPS12C

Details and patient eligibility

About

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

Full description

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.

Enrollment

34 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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