CTRI/2016/03/006727已完成1 期
A Phase-I, Pharmacokinetic and Pharmacodynamic Study of Darbepoetin alfa Injection, Hetero and ‘ARANESP®’ (Darbepoetin alfa Injection, Amgen), in Healthy Adult Human Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- PD Endpoints
研究概览
简要总结
This is a phase I, doubleblind, randomized, two-period, two-treatment, two-sequence, two-stage, two-part,crossover, balanced, single dose, pharmacokinetic and pharmacodynamic study oftwo formulations of Darbepoetin alfa administered by two different routes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age:18 to 45 years old, both inclusive
- •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.
- •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).
- •Volunteer having body weight ≤80 Kg
- •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%].
- •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].
- •Able to communicate effectively with study personnel.
- •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.
- •Results within normal limits or clinically non-significant for the laboratory tests.
排除标准
- •History of allergic responses to Darbepoetin alfa or other related drugs, or any of its formulation ingredients.
- •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)].
- •Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •Haemoglobin at baseline greater than 12 g/dL
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •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.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- •Intolerance to venipuncture
- •Volunteer having positive urine screen for drugs of abuse.
结局指标
主要结局
PD Endpoints
时间窗: NA
PK Endpoints
时间窗: NA
Cmax, AUCt and AUCi
时间窗: NA
T/R ratio will be reported for AUCt, AUCi and Cmax.
时间窗: NA
Baseline adjusted AUECHb
时间窗: NA
次要结局
- PK Endpoints(AUCt/AUCi, Tmax, Kel and t1/2)
- PD Endpoints(Change in haematocrit, Change in reticulocyte count, Maximum Hb, Maximum hematocrit, Maximum reticulocyte count achieved)
研究者
研究点 (1)
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