NCT01643759已完成1 期
A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.
详细描述
After up to 7-day screening period, Eligible Patients will be randomized to 1 of 3 treatment groups, and begin treatment with BTDS 5mg, 10mg,20mg for 7 days.Venous blood will be collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216, 240 h postdose respectively.Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, Tmax, t½.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients volunteering for participation in the study.
- •Male and female patients with diagnosis of osteoarthritis, age from 20 to 60 years.
- •Body weight ≥ 50kg , and BMI range ≧ 18.5, ﹤
- •Having the results within the following ranges and having been judged as eligible for the study participation by the investigator:Systolic blood pressure (supine), 90-140 mm Hg,Diastolic blood pressure (supine), 60-90 mm Hg, Armpit body temperature, 35.0-37.5 degree Celsius.
- •Agreed not to use any medication (except vitamins or mineral supplements) during the course of the study.
- •Have not smoked or chewed tobacco for at least 45 days prior to dosing with study drugs, and agree not to use tobacco products during the study.
- •Females of childbearing potential must have a negative serum pregnancy test during screening visit and at check-in.
排除标准
- •Subjects who have been taking opioid analgesic formulations excess 7 days within 3 months of Visit
- •Subjects who have been taking CYP3A4 inhibitor or inducer within the last 1 month prior to the screening visit.
- •Subjects who have been taking any medication including OTC (except vitamin and/or mineral supplements) within 7 days prior to the first dose of the trial product.
- •Patients who have a current chronic disease(s), or who have a past history and high possibilities to relapse, in addition to their musculo-skeletal pain, requiring frequent analgesic therapy.
- •Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
- •Subject who have a past history of malignant neoplasm.
- •Subjects with clinically unstable, active or symptomatic heart disease.
- •Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.
- •Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
- •History of frequent nausea or emesis regardless of etiology.
- •Subjects who have a current or past history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period.
- •Subjects scheduled for therapies within the study period which might effect study assessment.
- •Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin during the Screening Period or who have severe impaired liver function.
- •Subjects with serum creatinine > 2 mg/dL during the Screening Period or who have severe impaired renal function.
- •Subjects with serum potassium < 3.5 mEq/L during the Screening Period.
- •Subjects with positive result of anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis C virus antibody or qualitative syphilis tests.
- •Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within 1 month prior to the start of the study.
- •Subjects who have a history of supersensitivity to study drug.
- •Subjects who participated in a clinical research study within 1 month of study entry.
- •Subjects who participated previously in a BTDS study.
研究组 & 干预措施
buprenorphine transdermal system
Experimental
buprenorphine transdermal system
干预措施: buprenorphine (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose.
次要结局
未报告次要终点
研究者
研究点 (1)
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