Anemia
Conditions
Keywords
CKD-11101, NESP, Darbepoetin alfa, Anemia, subcutaneous, Pharmacokinetics, Phase 1
Brief summary
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers
Detailed 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.
Interventions
DRUGNESP 60μg
Administrated NESP 60μg once subcutaneously
DRUGCKD-11101 60μg
Administrated CKD-11101 60μg once subcutaneously
Sponsors
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Cmax of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
| Assess AUClast of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
Secondary
| Measure | Time frame |
|---|---|
| Assess AUCinf of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
| Assess Tmax of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
| Assess t1/2 of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
| Assess CL of darbepoetin alfa | Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h |
Countries
South Korea
Outcome results
None listed