NL-OMON51629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 subjects - Pharmacodynamic study of a novel analgesic combination treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 64（—）
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
- •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
- •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,
- •tranquillisers, 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
- •12. Current use of tobacco or nicotine products and unable to abstain from use
- •of these products within the previous 3 months before the f
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
进行中（未招募）
1 期
A study to investigate the effects of two painkillers as a combination treatment for paiovel treatment combination for neuropathic pain in healthy male volunteersISRCTN30672343Centre 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