CTRI/2019/01/017346已完成1 期
A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in healthy adult human subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- To compare the Pharmacokinetics similarity of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection after administration of subcutaneous single dose in adult healthy human subjects.
研究概览
简要总结
This is a randomized, double-blind, single dose, two-arm, parallelstudy to compare the pharmacokinetics (PK), immunogenicity and safety of twopreparations of Adalimumab namely - Zydus Adalimumab (ZRC-3197) Injectionand HUMIRA® Adalimumab Injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •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 between 50 to 85 Kg (both inclusive).
- •Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- •Able to communicate effectively with study personnel.
- •Able to give written informed consent to participate in the study.
- •Able to signed and dated written informed consent prior to any study-specific procedures, Willing and able to comply with the study procedures, restrictions and requirements.
- •Volunteers who are negative for drugs of abuse and alcohol breath tests at screening.
- •Male Volunteers should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child during the course of the study and 03 months after administration of study medication.
排除标准
- •History of allergic responses/exposure to Adalimumab or HUMIRA or other related drugs, or antibodies.
- •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 (for female volunteers)].
- •Any disease or condition like diabetes, psychosis or others which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to the study medication.
- •A depot injection or implant of any drug within 3 months prior to the study medication.
- •Use of enzyme-modifying drugs within 30 days prior to the study medication.
- •History of drug dependence or of alcoholism or of moderate alcohol use 9)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).
结局指标
主要结局
To compare the Pharmacokinetics similarity of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection after administration of subcutaneous single dose in adult healthy human subjects.
时间窗: pre-dose (0.0 hour) and at 0.333, 1.0, 4.0, 8.0, 12.0, 24.0, 48.0, 72.0, 96.0, 120.0, 144.0, 168.0, 192.0, 216.0, 264.0, 336.0, 384.0, 528.0, 696.0, 864.0, 1032.0, 1200.0, 1320.0, 1512.0 and 1704.0 hours post-dose
次要结局
- •To evaluate the potential immunogenicity of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in adult healthy human subjects.(•To assess and compare the safety and tolerability of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in adult healthy human subjects.)
研究者
研究点 (1)
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