ACTRN12614000514606已完成4 期
A randomised cross-over study comparing the pharmacokinetics of intranasal droperidol to intravenous droperidol in healthy volunteers:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
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
- Male
入选标准
- •Healthy adult males aged between 18 and 55 years
- •Body weight > 50kg and < 100 kg with BMI < 28
排除标准
- •Female gender
- •Allergy to droperidol
- •Previous history of any dystonic reaction to medications
- •Abnormal nasal anatomy
- •Previous nasal surgery or nasal trauma that may interfere with administration of absorption of intranasal medication
- •Current or recent upper respiratory tract infection
- •Use of any prescription or non-prescription drugs that may affect droperidol metabolism or nasal physiology (vasoconstrictors e.g. phenylephrine) within the past seven days
- •Treatment with medication known to prolong the QT interval
- •Absolute QT calculated as the average of three limb lead and three chest lead (V2-V4) QT interval duration.
- •Abnormal 12-lead ECG on screening with QTcorrected> 480 msec using Sagie regression QTc calculation formula and correlated with Isbister QT-heart rate pair nomogram.
- •Any known cardiovascular, gastrointestinal, pulmonary, renal, haematologic or liver disease
- •Any psychiatric or mental health disorder or previous history of antipsychotic medication use
研究者
相似试验
进行中（未招募）
1 期
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2013-005543-90-DEAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2013-005543-90-EEAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.Rheumatoid arthritisEUCTR2013-005543-90-BGAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.Rheumatoid arthritisEUCTR2013-005543-90-PLAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2013-005543-90-HUAmgen Inc300