CTRI/2013/06/003767已完成未知
on-randomized, open-label, single dose, four arm, two-period, two-way crossover scintigraphy study to evaluate the dispersion pattern of an antacid tablet after three methods of oral administration in comparison to antacid suspension in 4 healthy male volunteers under fasting and fed conditions.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4
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
入选标准
- •Healthy male volunteers with age ranging from 18 to 45 years
- •Non-smokers
- •Written informed consent by volunteers.
- •Volunteers willing to follow up
排除标准
- •Patient with existing GI disease (loose motion, acidity, vomiting, ulcers)
- •Patient who have undergone GI surgery.
- •Patients with known hypersensitivity to model antacid, to compounds structurally related to the study drugs or to any other component included
- •History of hypersensitivity to any allergens known to them
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric or any other body system involvement
- •History of significant symptoms of cardiac dysfunction within one year
- •Any history or presence of significant alcoholism or drug abuse within past one year
- •History or presence of significant smoking (10 or more cigarettes per day) or consumption of tobacco products
- •History or presence of significant asthma, urticaria or other allergic reactions following antacid
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor
- •Blood pressure less than 90/60 (Systolic/ diastolic) mm Hg or more than 140/95 mm hg
- •Pulse less than 45/minute or more than 110/minute
- •Febrile patients
- •Use of any prescription medication during last two weeks or OTC medicinal products during the last one-week preceding the study
- •Major illness during 3 months before the screening period.
- •Subjects who have been on abnormal diet for whatever reason during 4 weeks preceding the study
- •Subjects who have participated in drug research study within past three months
- •A positive Pregnancy test in case of female volunteer of child bearing age
- •Subject planning to leave the area of study before completion of study
- •Planed participation in another clinical trial during the trial period
- •Any other condition that in the opinion of the investigator does not justify the patientâ??s participation in the study
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