Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000558
- Lead Sponsor
- Chong Kun Dang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 34
1)Signed the informed consent form prior to study participation.
2)A healthy male volunteer between 20 and 55 years old.
3)Body weight between 55kg and 90kg, BMI between 18 and 27.
4)Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)
1)Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
2)Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
3)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
4)A heavy smoker (cigarette > 10 cigarettes per day)
5)Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
6)Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
7)sit SBP < 90mmHg or sit SBP > 140mmHg or sit DBP < 55mmHg or sit DBP > 90mmHg or Pulse rate > 100 per/min
8)History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
9)Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
10)Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
11)A heavy alcohol consumer (alcohol > 21 units/week) or cannot stop drinking
12)Bleed or donate blood (> 400mL) within 8 weeks before the first IP administration
13)Participated in this clinical trials and administrated IP
14)Have a diet within 2 days before the first IP administration or cannot stop having
- food containing grapefruit
- food containing caffeine
15)Disagree to avoid getting pregnant during clinical trial
16)An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess AUClast, Cmax of darbepoetin alfa
- Secondary Outcome Measures
Name Time Method Assess AUCinf, Tmax, t1/2, CL of darbepoetin alfa