ACTRN12616000600448已完成1 期
A multiple dose, randomized, open label, bioequivalence study of a test formulation of buprenorphine transdermal patch in a 2 way crossover comparison against the innovator buprenorphine transdermal patch conducted under fasting conditions and at steady state with the inclusion of a naltrexone block in healthy male and female volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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 55 Years（—）
- 性别
- All
入选标准
- •Healthy male and non-pregnant females
- •Aged between 18 and 55
- •Non-smoker
- •BMI between 18.5 and 30 inclusive
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Able to provide written informed consent
排除标准
- •Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
- •Concomitant drug therapy of any kind
- •Sensitivity to buprenorphine or any other similar class of medicines, or the excipients of buprenorphine
- •Sensitivity to naltrexone or any other similar class of medicines, or the excipients of naltrexone
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Females who are pregnant and/or are breastfeeding
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
- •Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
研究者
相似试验
已完成
1 期
Comparative assessment of the absorption of a generic formulation of (2S)-2-[17-(cyclopropylmethyl)-4, 5a-epoxy-3-hydroxy-6-methoxy-6a, 14-ethano-14a-morphinan-7a-yl]-3, 3-dimethylbutan-2-ol transdermal patch against the innovator (2S)-2-[17-(cyclopropylmethyl)-4, 5a-epoxy-3-hydroxy-6-methoxy-6a, 14-ethano-14a-morphinan-7a-yl]-3, 3-dimethylbutan-2-ol transdermal patch conducted under fasting conditions with the inclusion of a naltrexone block in healthy male and female volunteers(2S)-2-[17-(cyclopropylmethyl)-4, 5a-epoxy-3-hydroxy-6-methoxy-6a, 14-ethano-14a-morphinan-7a-yl]-3, 3-dimethylbutan-2-ol is a partial opioid agonist indicated for the management of severe pain.Anaesthesiology - Pain managementACTRN12622000133730Zenith Technology Corporation Limited26
已完成
1 期
Comparative assessment of the absorption of a generic formulation of buprenorphine transdermal patch against the innovator buprenorphine transdermal patch conducted under fasting conditions with the inclusion of a naltrexone block in healthy male and female volunteersBioequivalence study conducted in healthy volunteers comparing two formulations of buprenorphine transdermal patch with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, buprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain.Bioequivalence study conducted in healthy volunteers comparing two formulations of buprenorphine transdermal patch with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, buprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12615001251516Zenith Technology Corp Ltd32
撤回
1 期
Comparative assessment of the absorption of a generic formulation of a combination N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension against two innovator formulations administered simultaneously of N-(4-hydroxyphenyl)acetamide oral suspension and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.-(4-hydroxyphenyl)acetamide is an effective analgesic and antipyretic. It is indicated for the temporary relief of pain, discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu, and it reduces fever.(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid is a nonsteroidal anti-inflammatory drug used for the temporary relief of fever, pain associated with teething, toothache, earache, sore throat, headache, minor ache, sprain, strain, cold and flu.N-(4-hydroxyphenyl)acetamide is an effective analgesic and antipyretic. It is indicated for the temporary relief of pain, discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu, and it reduces fever.Anaesthesiology - Pain managementInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12621001446853Zenith Technology Corporation Limited24
已完成
1 期
Comparative assessment of the absorption of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet administered 12 hours apart conducted under fasting conditions and at steady state in healthy volunteers.ACTRN12620000812998Zenith Technology Corporation Limited33
已完成
1 期
Comparative assessment of the absorption of a generic formulation of melatonin prolonged release tablet against the innovator melatonin prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteersBioequivalence study conducted in healthy volunteers comparing two formulations of melatonin with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, melatonin is a naturally occurring hormone produced by the pineal gland and is indicated as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.Bioequivalence study conducted in healthy volunteers comparing two formulations of melatonin with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, melatonin is a naturally occurring hormone produced by the pineal gland and is indicated as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12615000143527Zenith Technology Corp Ltd28