ACTRN12609000836235已完成1 期
A phase I study in healthy males to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
Phosphagenics Limited0 个研究点目标入组 44 人开始时间: 2009年9月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 49 Years（—）
- 性别
- Male
入选标准
- •Body Mass Index (BMI) must be greater than or equal to 19 and less than or equal to 30 kg/m2.
- •- Weight must be greater than 50kg
排除标准
- •History or evidence of drug and/or alcohol abuse; smokers; use of central nervous system (CNS) depressants, other opioids, sedative/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines; use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritanovir) within 30 days of study dosing; Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorders; History of epilepsy, coronary disease, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack; uncontrolled hypertension or signs/symptoms of ischaemic heart disease; Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia; Known allergy or hypersensitivity reactions to naltrexone or to oxycodone, or other opioid analgesics (codeine, fentanyl, hydrocodone, morphine etc.), or allergy to any contents of the gel (i.e., disodium tocopheryl phosphate (TP), sodium di-tocopheryl phosphate (T2P), pemulen gel, triethanolamine, methylparaben); Known allergy or hypersensitivity to lidocaine or Tegaderm(registered trademark) patches or to topical preparations, such as sunscreens; A calculated creatinine clearance (CL) of < 85ml/min; Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody; Have a history of low blood pressure (BP) or severe motion sickness e.g., hypotension where BP is persistently < 90/50 mmHg; Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.
研究者
相似试验
已完成
不适用
A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren(registered trademark) gelMuscular or joint pain relief in healthy volunteers currently experiencing no painOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12609000505202Phosphagenics Limited24
已完成
不适用
A phase 0 validation study in healthy male volunteers assessing the safety and tolerability of serial CSF sampling and to evaluate biomarkers related to Alzheimer*s disease in CSF and plasmaAlzheimer10029305NL-OMON36095QPS Netherlands B.V.8
进行中（未招募）
不适用
An open, single centre, phase I study in male adolescents with asthma, aged12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100mg twice daily for 6½ daysAsthmaEUCTR2010-021520-10-SEAstraZeneca AB21
尚未招募
不适用
Efficacy of Neelkanthi churna in Madhumeha w.s.r to Type 2 Diabetes MellitusCTRI/2021/06/034030Principal
已完成
1 期
A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritisActive Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritisACTRN12611000123943Santarus, Inc.74