NL-OMON42337已完成不适用
A randomized, double-blind, double dummy, placebo-controlled, four-way, cross-over, single dose study to investigate the effects of paracetamol and THC on the PainCart in healthy subjects using promethazine as negative control - PainCart validation: Paracetamol, THC and promethazine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;
- •2. Female subjects are required to have an intrauterine device, a contraceptive implant or are willing to continuously use oral contraceptives (i.e. skip their menstruation) during the study period;
- •3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg and a maximum weight of 100 kg;
- •4. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. Legal incapacity or inability to understand or comply with the requirements of the study;
- •2. Clinically significant findings as determined by medical and psychiatric history taking, physical examination, ECG and vital signs;
- •3. Haemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm;
- •4. Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etc.);
- •5. Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests;
- •6. Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening;
- •7. Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic;
- •8. History or clinical evidence of alcoholism or drug abuse;
- •9. Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
- •10. Use of prescription medication, over-the-counter medication, or herbal supplement within 7 days of nociceptive assessments;
- •11. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year;
- •12. Loss of blood >= 500 mL within 3 months (males) or 4 months (females) before screening;
- •13. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients;
- •14. Dark skin (Fitzpatrick skin type V or VI), wide-spread acne, tattoos or scarring on back; and/or
- •15. Subjects of childbearing potential who are unwilling or unable to use a highly effective barrier method of contraception for the duration of the study and for 3 months after the last dose of study treatment.
研究者
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