PK 0396 - Buprenorphine Dose Escalation Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Intoxication and withdrawal
研究概览
简要总结
The purpose of this study is to evaluate the effect, pharmacokinetics and dose proportionality of buprenorphine when administered to non-dependent opiate users. 1) To evaluate whether plasma concentrations of buprenorphine increase proportionally to buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects of buprenorphine; and 3) To determine the safety of buprenorphine.
详细描述
This will be an open-label, single dose-escalation trial. A total of 24 opiate experienced, but not dependent subjects will receive four ascending doses of buprenorphine, 4, 8, 16, and 24 mg, respectively, with an at least a 14 day washout interval between treatments. The four treatments are sublingual administration of:
- two 2-mg buprenorphine sublingual tablets,
- one 8-mg buprenorphine sublingual tablet,
- two 8-mg buprenorphine sublingual tablets; and
- three 8-mg buprenorphine sublingual tablets.
The dose proportionality in plasma profiles of buprenorphine and dose response of the buprenorphine sublingual tablets are evaluated at buprenorphine dose range of 4 to 24 mg.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female of any race, between 21 and 45 years of age.
- •Weigh within 15% of ideal body weight for height according to the current life insurance table.
- •Be in good physical and mental health as judged by interview and physical examination.
- •Have no significant oral cavity pathology including excessive caries, gingivitis, infectious or inflammatory disease, or recent piercing of the oral cavity.
- •Be experienced in illicit use of opiates but not be physically dependent on opiates and other drugs (except nicotine or caffeine) at the time of the study. A history of other psychoactive drug use is acceptable but preference will be for subjects reporting less frequent and more controlled illicit drug use.
- •For female subjects, test nonpregnant and use adequate birth control, and not be lactating.
- •Be capable of providing written informed consent to participate in this study.
- •Be able to comply with protocol requirements and be likely to complete all four study treatments.
排除标准
- •Have a diagnosis of drug addiction (other than nicotine, caffeine, and opiate) as per DSM-IV criteria.
- •Have any significant, active medical or psychiatric illnesses (other than drug dependence) which might inhibit their ability to complete the study or might be complicated by administration of study medications.
- •Have clinically significant abnormal laboratory measurements in liver function tests (AST and ALT levels greater than 3 times the upper limit of normal), hematology (CBC, differential, platelet count), serum chemistries (SMA-24) and urinalysis at screening.
- •Test positive on the HIV blood screen.
- •Have a history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders.
- •Have known hypersensitivity to buprenorphine and its derivatives or opiates or opiate-like analgesics.
- •Receive any medications for medical conditions.
- •Have any condition or history considered by the investigator(s) to place the subjects at increased risk.
- •Do not actively meet the inclusion criteria at the time of screening.
结局指标
主要结局
Intoxication and withdrawal
PK parameters of buprenorphine
次要结局
未报告次要终点