Back to results

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

Primary Purpose

Anemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NESP 60μg

CKD-11101 60μg

About this trial

This is an interventional treatment trial for Anemia focused on measuring CKD-11101, NESP, Darbepoetin alfa, Anemia, intravenous, Pharmacokinetics, Phase 1

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NESP 60μg

CKD-11101 60μg

Arm Description

Prefilled syringe filled with Darbepoetin alfa 60μg

Outcomes

Primary Outcome Measures

Assess AUClast of darbepoetin alfa

Assess Cmax of darbepoetin alfa

Secondary Outcome Measures

Assess AUCinf of darbepoetin alfa

Assess Tmax of darbepoetin alfa

Assess t1/2 of darbepoetin alfa

Assess CL of darbepoetin alfa

Full Information

NCT ID

NCT01684605

First Posted

September 11, 2012

Last Updated

May 22, 2017

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01684605

Brief Title

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

Official Title

A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After IV Administration in Health Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 12, 2012 (Actual)

Primary Completion Date

November 13, 2012 (Actual)

Study Completion Date

January 3, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

CKD-11101, NESP, Darbepoetin alfa, Anemia, intravenous, Pharmacokinetics, Phase 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NESP 60μg

Arm Type

Active Comparator

Arm Description

Prefilled syringe filled with Darbepoetin alfa 60μg

Arm Title

CKD-11101 60μg

Arm Type

Experimental

Arm Description

Prefilled syringe filled with Darbepoetin alfa 60μg

Intervention Type

Drug

Intervention Name(s)

NESP 60μg

Intervention Description

Administrated NESP 60μg once intravenously

Intervention Type

Drug

Intervention Name(s)

CKD-11101 60μg

Intervention Description

Administrated CKD-11101 60μg once intravenously

Primary Outcome Measure Information:

Title

Assess AUClast of darbepoetin alfa

Time Frame