ISRCTN30672343进行中（未招募）1 期
A randomized, double-blind, double dummy, placebo-controlled, four-way cross-over study to investigate the analgesic effects and CNS effects of morphine and pregabalin in healthy subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •1. Healthy subjects, 18 to 65 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. 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.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions
排除标准
- •1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- •2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening.
- •5. Abnormal findings in the resting ECG at screening defined as:
- •a. QTcF> 450 or < 300 msec for men and QTcF> 470 or < 300 msec for women
- •b. Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm)
- •c. Personal or family history of congenital long QT syndrome or sudden death;
- •d. ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
- •e. Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker
- •6. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day), which are allowed up to 2 days before screening and 2 days before each study drug administration. Other exceptions will only be made if the rationale is clearly documented by the investigator.
- •7. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator.
- •8. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study).
- •9. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units (for males) or 14 units (for females) of alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquilizers, or any other addictive agent
- •10. Positive test for drugs of abuse at screening or pre-dose.
- •11. Alcohol will not be allowed from at least 24 hours before screening or each admission.
- •12. Current use of tobacco or nicotine products and u
研究者
相似试验
进行中（未招募）
1 期
A randomized, double-blind, double dummy, placebo-controlled, four-way cross-over study to investigate the analgesic effects and CNS effects of morphine and fluvoxamine in healthy subjects.Chronic painMedDRA version: 20.1Level: LLTClassification code: 10049475Term: Chronic pain Class: 10018065CTIS2023-505793-15-00Centre for Human Drug Research24
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 controlPainAlgesiapainNL-OMON42337Centre for Human Drug Research24
已完成
不适用
A randomized, double-blind, double dummy, placebo-controlled, four-way cross-over study to investigate the analgesic effects and CNS effects of morphine and pregabalin in healthy subjectsChronic PainNL-OMON51629Centre for Human Drug Research24
已完成
不适用
A randomized, double-blind, double-dummy, placebo-controlled, single dose, 4-way cross-over study of the reversibility of cognitive deficits induced by a nicotinic anti-cholinergic challenge with mecamylamine by a cholinesterase inhibitor and a nicotinic receptor agonistAlheimer's disease10057167NL-OMON42052Centre for Human Drug Research28
招募中
4 期
A clinical trial to understand changes in exhaled breath and lung function tests with different doses of inhaled steroid (Beclomethasone dipropionate) in moderate to severe asthma patients.CTRI/2018/02/011953Chest Research Foundation