NCT02172417已完成1 期
The Effect of Concomitant Cimetidine p.o. 400 mg t.i.d. and p.o. Ranitidine 300 mg Once Daily on Single Dose Pharmacokinetics of Tiotropium (14.4 µg) Given Intravenously Over 15 Minutes in Healthy Male and Female Subjects of 50-65 Years (Randomized, Open Label, Two Independent Two-fold Crossover)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Renal clearance of tiotropium (CLR)
研究概览
简要总结
Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females
- •Age range from 50 to 65 years
- •Within 20% of their normal weight (Broca index)
排除标准
- •Any finding of the medical examination (including blood pressure, puls rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study or during the study (exclusion: ovarian hormone substitution)
- •Use of any drugs which might influence the results of the trial within four weeks prior to administration or during the trial, among these all non-selective β-blockers, cromolyn sodium, nedocromil sodium, oral β-adrenergics or long-acting β-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT® (ipratropium) by oral inhalation or ATROVENT® Nasal Spray
- •Participation in another study with an investigational drug within two months prior to administration or during the trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 40 g/day)
- •Drug abuse
- •Blood donation (≥ 100 ml) within four weeks prior to administration or during the trial
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Any laboratory value outside the reference range of clinical relevance
- •Subjects with known hypersensitivity to anticholinergic drugs
- •Subjects with known symptomatic prostatic hypertrophy or disturbed micturition
- •Subjects with known narrow-angle glaucoma
- •In addition for female subjects (if appropriate):
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception e.g. oral contraceptives, sterilization, intra uterine pessary (IUP)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Cimetidine + Tiotropium followed by Tiotropium
Experimental
干预措施: Cimetidine + Tiotropium (Drug)
Cimetidine + Tiotropium followed by Tiotropium
Experimental
干预措施: Tiotropium (Drug)
Ranitidine + Tiotropium followed by Tiotropium
Experimental
干预措施: Ranitidine + Tiotropium (Drug)
Ranitidine + Tiotropium followed by Tiotropium
Experimental
干预措施: Tiotropium (Drug)
结局指标
主要结局
Renal clearance of tiotropium (CLR)
时间窗: pre-dose, 0-4 h, 4-8 h, 8-12 h, 12-24 , 24-28 h, 38-72 h and 72-96 h after i.v. treatment
Urinary excretion 0-4h after dosing (Ae0-4h)
时间窗: 0 - 4 hours after i.v. treatment
Cmax of plasma levels of tiotropium after dosing
时间窗: up to 8 hours after i.v. treatment
Area under the curve (AUC) 0-4h of the plasma levels of tiotropium after dosing
时间窗: 0 - 4 hours after i.v. treatment
次要结局
- Changes from baseline in physical examination(Baseline, 4 - 8 days after last i.v. treatment)
- Changes in 12-lead electrocardiogram (ECG)(up to 24 h after i.v. treatment)
- Occurrence of Adverse Events(up to 4 - 8 days after last i.v. treatment)
- AUC 0-8h of plasma levels of tiotropium after dosing(0-8 hours after treatment)
- Changes in Blood Pressure and Pulse Rate(up to 4 - 8 days after last i.v. treatment)
- Urinary excretion 0-96h after dosing (Ae0-96h)(0-96 hours after treatment)
- Changes from baseline in Laboratory Tests(Baseline, 4 - 8 days after last i.v. treatment)
研究者
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