EUCTR2011-001325-25-SE进行中（未招募）不适用
A phase I study to assess the pharmacokinetic profile of sublingual OX27 tablets in single and repeated doses in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Orexo AB
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent obtained before any trial procedures
- •2. Healthy male or female volunteer, 18–55 years of age (inclusive), with suitable veins for cannulation or repeated venipuncture
- •3. Vital signs: pulse within 45–90 bpm, systolic blood pressure within 90–140 mmHg, diastolic blood pressure within 50–90 mmHg (extremes included)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Weight outside normal, i.e., body mass index (BMI) not within 18.5–30 kg/m2 (inclusive)
- •2. Daily use of nicotine products within six months before the first dose of OX27 (Occasional smoking is allowed, but not usage of snuff or substitute for snuff).
- •3. Any intake of alcohol within 72 hours before Day -1 of Visit 2
- •4. Any drug abuse according to drug screen tests
- •5. Hepatitis B or C according to diagnostic tests
- •6. HIV according to diagnostic test
- •7. Use of prescription medication (except oral contraceptives), over-the-counter (OTC) medication or herbal remedies within 14 days before Day -1 of Visit 2, or within five half-lives of the drug, whichever is longer
- •8. Use of CYP3A4 substrates, inducers or inhibitors within 2 weeks before Day -1 of Visit 2 or during the trial (other than those administered as part of the trial)
- •9. Ingestion of grapefruit or grapefruit juice within 72 hours before Day -1 of Visit 2
- •10. Any known hypersensitivity to sufentanil, naltrexone or other opioids
- •11. Pregnant or breastfeeding woman or woman not using adequate birth control (e.g., intrauterine device, barrier method, per oral contraceptive, hormone injection or implants)
- •12. Participation in any other clinical trial and/or intake of any investigational drug within 30 days (or five half-lives of the drug, whichever is longer) before Visit 1
- •13. In the Investigator’s judgement, clinically significant abnormalities at the screening examination or in the laboratory test results
- •14. Donation of blood or plasma to a blood bank or in a clinical trial (except Visit 1) within 3 months before
- •15. Any history of drug or alcohol abuse
- •16. Clinically significant lung disease as judged by the Investigator, or sleep apnoea, or narcolepsy
- •17. Clinically significant ECG abnormalities or arrhythmia at screening or on Day -1 (at Visit 2) as judged by the Investigator
- •18. Any symptom of infection within 6 days before first dose of OX27
- •19. Subject has any disease affecting the oral cavity that may affect the sublingual mucosa, for example Candida Albicans or any pre-existing oral mucosal lesion
- •20. Any use of dental whitening treatments within 1 week prior to first OX27 administration (whitening toothpaste is allowed)
- •21. Subject has oral pathology or dental devices, which may affect absorption from the sublingual space
- •22. Subject has current piercings of tongue or lip (historical piercings that are completely healed are acceptable)
研究者
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