NCT06326671进行中（未招募）1 期
A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Trial to Assess the Bioequivalence of Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) in Healthy Adult Participants Under Fasting Conditions (Pilot)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) 0-t
研究概览
简要总结
Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs);
- •Able to complete the trial in compliance with the protocol;
- •Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 3 months after the last scheduled visit;
- •Males and females between 18 and 55 years old (included);
- •At least 50 kg for males, 45 kg for females, with a Body Mass Index (BMI) = Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2 (included);
- •No history of cardiac, hepatic, renal, ophthalmology and otorhinolaryngology, respiratory system, urogenital system, digestive tract, nervous system, mental and metabolic disorders, etc.
排除标准
- •Take ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial, or urine nicotine test is positive;
- •Be allergic to tiotropium, atropine or its derivatives (e.g., ipratropium, oxitropium) or any excipient of tiotropium bromide inhalation sprays; or allergic constitution (be allergic to two or more drugs, food and pollen allergy); or with specific allergy history (asthma, urticaria, eczema, etc.);
- •A history of alcohol abuse (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine);
- •Blood donation or massive blood loss (≥ 400 mL) within 3 months before the initial administration; Or any blood donation plan from screening until 1 month after the last administration;
- •Participants who have an acute upper respiratory tract infection within 2 weeks prior to receiving investigational product;
- •History of any clinically significant diseases or any other diseases that could interfere with the study results. Including but not limited to the circulatory system, gastrointestinal system, urinary system (such as history of prostate hypertrophy, bladder neck obstruction, uroschesis, etc.), respiratory system (such as acute onset of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, bronchospastic pulmonary disease, bronchial asthma, etc.), ophthalmology (such as: glaucoma, etc.), nervous system, immune system, endocrine system, malignant tumor, mental and metabolic abnormalities; or with history of nasopharyngitis, throat ulcers, edema, or history of throat, tracheal/bronchial and lung surgery in the past;
- •History of sicca syndrome or habitual constipation;
- •Function test: the forced expiratory volume in one second measured value / the forced expiratory volume in one second predicted value ≤80% or the forced expiratory volume in one second / forced vital capacity ≤80%;
- •Any prescription medication within 14 days before the initial administration;
- •Any over-the-counter (OTC) medication or Chinese herbal medicine or health supplementary within 7 days before the initial administration;
- •Consumption of any special diets (such as grapefruit), or strenuous exercise engagement, or other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration;
- •Participation in other drug clinical trials within 3 months before the initial administration;
- •Any clinically significant abnormality findings, as judged by a clinical physician, such as physical examination, vital signs, electrocardiogram, chest X-ray examination and laboratory tests;
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis;
- •Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 hours before the initial administration;
- •Consumption of any products containing alcohol within 48 hours before the initial administration, or a positive result of the alcohol breath test;
- •A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial;
- •A positive result of the pregnancy test, or in lactation during screening or the test period for female participants;
- •History of fainting needle or blood;
- •Not tolerable on venipuncture, or a history of difficulty in venous blood collection;
- •Special requirements and unable to follow the unified diet, or intolerance to lactose or galactose;
- •Unable to participate in this trial for participants' own reasons;
- •Participants who cannot control of powder inhaler oral inhalation correctly after training;
- •Other conditions in which participants are not suitable for the trial determined by investigators.
研究组 & 干预措施
Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg)
Experimental
The subjects randomly received single oral inhalation dose of Tiotropium bromide inhaling powder generic product.
干预措施: Tiotropium Bromide Inhalation Powder (Drug)
Reference Product (Spiriva®Handihaler®, Strength: 18 mcg)
Active Comparator
The subjects randomly received single oral inhalation dose of the reference listed drug (RLD) Spiriva®Handihaler®.
干预措施: Spiriva HandiHaler (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) 0-t
时间窗: Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
plasma concentration-time curve from zero to the time of the last measurable time point t.
Area under the plasma concentration versus time curve (AUC) 0-∞
时间窗: Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
area under the plasma concentration-time curve from zero to infinity
Peak concentration (Cmax)
时间窗: Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
Maximum plasma drug concentration
次要结局
- Terminal elimination rate constant (Kel)(Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose)
- The time to maximum plasma concentration (Tmax)(Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose)
- The elimination half-life (t1/2)(Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose)
研究者
研究点 (1)
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