CTRI/2010/091/000419已完成4 期
A Single Centre, Three Treatment, Three Way, Single Oral Dose, Crossover Scintigraphic Study To Investigate The Three Rapid Release Solid Dosage Forms Of Paracetamol Either Tablets Or Granules In Eight Healthy Human (Male And Female) Subjects Under Fasting Condition.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
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
- •1. Human subjects aged between 18 and 55 years (including both)
- •2. Subjects weight within ± 15% of the ideal height-weight chart of Life Insurance Corporation of India for non medical cases.
- •3. Ability to communicate effectively with study personnel.
- •4. Willingness to adhere to protocol requirement
- •5. Be able to give consent for participation in the trial.
- •6. Normal healthy as determined by person medical history, clinical examination and laboratory examinations data during screening. (Within clinically acceptable range)
排除标准
- •1. History of hypersensitivity to any allergens known to them
- •2. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric or any other body system involvement.
- •3. History of significant symptoms of cardiac dysfunction within one year
- •4. Any history or presence of significant alcoholism or drug abuse within past one year.
- •5. History or presence of significant smoking (10 or more cigarettes per day) or consumption of tobacco product
- •6. History or presence of significant asthma, urticaria or other allergic reactions following aspirin
- •7. History or presence of significant gastric and/or duodenal ulceration
- •8. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •9. History or presence of cancer.
- •10. Blood pressure less than 90/60 (Systolic/ diastolic) mm Hg or more than 140/95 mm hg.
- •11. Pulse less than 45/minute or more than 110/minute.
- •12. Febrile
- •13. Use of any prescribed medication during last two weeks or OTC medicinal products during the last one-week preceding the study.
- •14. Major illness during 3 months before the screening period.
- •15. Subjects who have been on abnormal diet for whatever reason during 4 weeks preceding the study.
- •16. Subjects who have participated in drug research study within past three months.
- •17. A positive Pregnancy test in case of female volunteer of child bearing age
研究者
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