Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- bioavailability of naloxone
研究概览
简要总结
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal electrocardiogram (ECG)
- •Hemoglobin: male 13.4 - 17.0 g/dL, female 11,7- 15.3 g/dL
- •Creatinine: male 60- 105 micromol/L female 45- 90 micromol/L
- •ASAT: male 15- 45 U/L, female 15- 35 U/L
- •ALAT: male 10- 70 U/L female 10- 45 U/L
- •Gamma GT: male 10- 80 U/L female 10- 45 U/L
- •HCG normal under 3 ye/L
- •Fertile women must use safe contraception and have a negative serum HCG at inclusion
排除标准
- •Taking any medications including herbal medicines the last week prior to first treatment visit
- •History of drug abuse
- •History of prior drug allergy
- •Having any local nasal disease or nasal surgery or recent cold for the last week
- •Pregnancy
- •Fertile women not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper IUD, Sterilization) throughout the study period until their last visit.
- •Lactating women
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究组 & 干预措施
nasal naloxone
8 and 16 mg/ml, comparator 1 mg/ml. Three daily occasions with at least 3 days washout between treatment (min 8 days).
干预措施: nasal naloxone (Drug)
结局指标
主要结局
bioavailability of naloxone
时间窗: 2 weeks
A LCMSMS method for determination of Naloxone in serum was developed using acetonitrile protein precipitation. Naloxone D5 was used as internal standard and quantitative determination was done by using Sciex Analyst version 1.5. The method is fully validated by assessing linearity, accuracy, precision, sensitivity, specificity/selectivity, in process and storage stability, dilution integrity and assay ruggedness according to Dadgar (1995) and Shah (1991). The method was found linear, accurate and precise across the dynamic range of 0.05 to 45 ng/ml. Limit of quantification (LOQ) was 0.05ng/ml with CV = 12.7% and inaccuracy \< 7.8% (n = 17). Quality Controls (QC) in middle (n=18) and upper (n=18) calibration range had CV \< 4.2% and inaccuracy \<8.2 %
次要结局
- Maximum serum concentration (Cmax)(2 weeks)
- Time to maximum serum concentration (Tmax)(2 weeks)
- adverse events(2 weeks)