ACTRN12612000059864已完成1 期
A two part, open label, phase I single and repeat Investigational Product application study in healthy volunteeers, to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal TPM/O patch.
Phosphagenics Limited0 个研究点目标入组 65 人开始时间: 2012年1月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Participant is free from clinically significant illness or disease as determined by screening and check-in assessments
- •2. BMI is equal to or greater than 19 and is equal to or less than 27 kg/m2
- •3. Weight > 50kg
- •4. Adequate venous access for collection of a number of blood samples.
排除标准
- •1. Evidence of any clinically significant impairment/disorder
- •2. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease
- •3. Current use of CNS depressants
- •4. Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1
- •5. A calculated creatinine clearance of < 85ml/min
- •6. Positive HIV antibodies, Hep B surface antigen or Hep C antibody test
- •7. History of epilepsy or any convulsive disorder
- •8. Any pre-existing medical conditions predisposing the participant to hypoventilation or hypoxaemia including diagnosed obstructive sleep apnoea
- •9. Systolic BP of < 90 mmHg or >140 mmHg and/or diastolic BP of < 50 mmHg or >95 mmHg
- •10. Known intolerance to naltrexone, naloxone, oxycodone, or other opioid analgesics or any commercially available adhesives
- •11. Any history of a recurrent generalised skin disorder <5 yrs
- •12. Any tattoos, scars or skin lesions on the area of IP application
- •13. History/evidence of drug or alcohol abuse and/or positive urine/breath test
- •14. Not able to abstain from alcohol, caffeine, smoking or other xanthine-containing products
- •15. Smoked avg. of =1 cigarettes/tobacco per mth in last 12 mths
- •16. Use of any prescription medication, over the counter products, herbal product, diet aid, or hormone supplement 14 days prior to study dosing
- •17. Consumption of grapefruit products, or any products containing CYP3A4 inhibitors and inducers within 14 days prior to the first day of study confinement
- •18. Males and females of childbearing potential who are unwilling or unable to use an acceptable method of double barrier contraception
- •19. Pregnant or lactating females.
研究者
相似试验
进行中（未招募）
不适用
A phase 1 open label/phase 2 randomized, double-blind, multicenter study investigating the combination of RAD001 and sorafenib (Nexavar®) in patients with advanced hepatocellular carcinomaadvanced hepatocellular carcinomaEUCTR2008-004096-21-DEovartis Pharma Services AG130
进行中（未招募）
1 期
A phase 1 open label/phase 2 randomized, double-blind, multicenter study investigating the combination of RAD001 and sorafenib (Nexavar®) in patients with advanced hepatocellular carcinoma - NAadvanced hepatocellular carcinomaEUCTR2008-004096-21-NLovartis Pharma Services AG
进行中（未招募）
1 期
An open-label, two-part study to investigate the drug-drug interaction potential of INE963 and KAE609 administered together, and the effect of food on pharmacokinetics and safety of INE963 in healthy participants.Infections and InfestationsMalariaISRCTN17232240ovartis Pharmaceuticals UK Limited30
已完成
不适用
A study to evaluate the safety and efficacy of Varlitinib in combination with weekly paclitaxel in EGFR/HER2 co-expressing advanced or metastatic gastric cancer.KCT0003583Yonsei University Health System, Severance Hospital73
已完成
1 期
Phase 1 study to evaluate the pharmacokinetics, safety, tolerability, and taste of tecovirimat pediatric formulationsISRCTN13846827Siga Technologies (United States)12