A clinical study to evaluate the Pharmacokinetic and Pharmacodynamic properties of Darbepoetin alfa Injection, Hetero and â??ARANESP®â?? (Darbepoetin alfa Injection, Amgen), in Healthy Adult Human Subjects
- Registration Number
- CTRI/2016/03/006727
- Lead Sponsor
- Hetero Drugs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
1. Age:18 to 45 years old, both inclusive
2. Sex: Male and/or non-pregnant, non-lactating female
a. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to initiation of the study & prior to check-in of each period. They must be using an acceptable form of contraception
b. For female of childbearing potential, acceptable forms of contraception include the following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
iii. Surgical sterilization or
iv. Practicing sexual abstinence throughout the course of the study
c. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months.
3. BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g., 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
4. Volunteer having body weight <=80 Kg
5. Adequate liver and kidney function [AST, ALT, alkaline phosphatase and bilirubin <=1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%].
6. Adequate Iron & Haemoglobin [Adequate iron stores (transferrin saturation >=20% and serum ferritin >=200 ng/mL or within laboratory reference range), total iron binding capacity, serum vitamin B12 and folate within laboratory reference range and blood haemoglobin not above 12.0 g/dL].
7. Able to communicate effectively with study personnel.
8. Able to give written informed consent to participate in the study.
9. All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
a. A physical examination with no clinically significant finding.
b. Results within normal limits or clinically non-significant for the laboratory tests
1. History of allergic responses to Darbepoetin alfa or other related drugs, or any of its formulation ingredients.
2. Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers)].
3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
4. Haemoglobin at baseline greater than 12 g/dL
5. History or presence of bronchial asthma.
6. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
7. A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
10. History of difficulty with donating blood or difficulty in accessibility of veins.
11. A positive hepatitis screen (includes subtypes B & C).
12. A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
13. Intolerance to venipuncture
14. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteerâ??s participation in this study.
15. Volunteer having positive urine screen for drugs of abuse.
16. Volunteer having positive alcohol breath test.
17. Receipt of live vaccine within 4 weeks prior to the first dose of study medication.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method