CTRI/2016/03/006727已完成1 期
A Phase-I, Pharmacokinetic and Pharmacodynamic Study of Darbepoetin alfa Injection, Hetero and â??ARANESP®â?? (Darbepoetin alfa Injection, Amgen), in Healthy Adult Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •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
排除标准
- •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.
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