ACTRN12621001446853撤回1 期
A single dose, randomized, open label bioequivalence study of a generic formulation of 10ml of a combination 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension in a 2 way crossover comparison against two innovator formulations administered simultaneously of 5 ml of 250 mg of N-(4-hydroxyphenyl)acetamide oral suspension and 5 ml of 100 mg of (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 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
- 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 males and females
- •Aged between 18 and 55
- •Non-smoker
- •BMI between 18 and 33 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 any of the medicines or ingredients
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •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 30 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
已完成
1 期
Comparative assessment of the absorption of a generic formulation of tiotropium test product 1 and tiotropium test product 2 against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteersACTRN12615000073505Zenith Technology Corp Ltd24
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 and at steady state with the inclusion of a naltrexone block in healthy male and female volunteersBuprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain.Anaesthesiology - Pain managementACTRN12616000600448Zenith Technology Corp Ltd36
已完成
1 期
Comparative assessment of the absorption of a generic formulation of Inhaled Insulin against the innovators Humalog KwikPen for injection and the AFREZZA Inhalation Powder Cartridge conducted under fasting conditions in healthy male and female volunteersPharmacokinetic and pharmacodynamic study conducted in healthy volunteers comparing three formulations of Insulin with no health condition or problem studied. Insulin is a medicine that is used to lower blood glucose.Pharmacokinetic and pharmacodynamic study conducted in healthy volunteers comparing three formulations of Insulin with no health condition or problem studied.Insulin is a medicine that is used to lower blood glucose.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12615001100583Zenith Technology Corp Ltd21