EUCTR2016-000539-42-NL进行中（未招募）1 期
A randomised, single dose, crossover, open label, placebo controlled confirmatory study in healthy volunteers to characterise the acid neutralisation activity of Gaviscon Double Action Liquid in the fasted state, using an intragastric and oesophageal pH catheter. - Acid Neutralisation confirmatory pH monitoring study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Only subjects to whom all of the following conditions apply will be included:
- •1.Male or female subjects who have given written informed consent.
- •2.Age: = 18 years = 50 years.
- •3.Body Mass Index (BMI): = 18.5 and = 24.9 kg/m2.
- •4.Height = 1.90 metres
- •5.Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-A history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
- •-Clinically significant diseases of the body system.
- •-A medical history that is associated with an increased risk in study procedures (e.g. basal skull fracture or those who have undergone trans-sphenoidal surgery).
- •-Hospitalisation within the previous three months for major surgery or medical illness.
- •-A clinically significant illness within the 4 weeks prior to screening.
- •-Ingestion of any prescription medication or non-prescription medication within the seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
- •-Ingestion of antacids, H2 antagonists, motility stimulants (e.g. prokinetics, macrolide antibiotics such as erythromycin and azithromycin, and 5-hydroxytryptamine [5HT] agonists such as sumatriptan) or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study and/or have taken proton pump inhibitors in the 4 weeks prior to enrolment into the study and during the study. Enrolment is defined as the date of informed consent signature.
- •-Those who are currently taking any of the following medications: antihistamines, tetracyclines, digoxin, quinolones including fluoroquinolone, iron salts, neuroleptics, thyroxine and levothyroxine, penicillamine, beta-blockers (e.g. atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, biphosphonates, ketoconazole, eltrombopag and Thiazide diuretics.
- •-A history of drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study.
- •-A history of allergy or intolerance to either IMP or the following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer, xanthan gum.
- •-A current or recent history (within one year of the screening visit) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents.
- •-Those with a positive screen/test for drugs of abuse and/or alcohol.
- •-Those who regularly (weekly) consume excessive amounts of alcohol (> 8 units for men and > 6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics).
- •-Those who have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit and from the screening visit up to 48 hours before admission to the Clinical Unit for Treatment Period 1.
- •-Those who have consumed alcohol within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
- •-Those who regularly consume excessive quantities of caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator’s judgement.
- •-Those who have consumed caffeine-containing food and drinks within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
- •-Those who are either unable to refrain from using tobacco/nicotine during the study trea
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