CTRI/2010/091/002992已完成1 期
A phase I, open label, balanced, randomized, two-period (fasting versus fed), two-sequence, cross-over, single-dose food effect study of P2202 of Piramal Life Sciences Limited, India in healthy, adult, male human subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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 human volunteers within the age range of 18 to 55 years (both inclusive)
- •-Non-smokers since at least six months
- •-Willingness to provide written informed consent to participate in the study
- •-Body-mass index of at least 18.5 kg/m2 and less than or equal to 24.9 kg/m2, with body weight not less than 50 kg
- •-Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening
- •-Normal 12-lead ECG or one with abnormality considered to be clinically insignificant
- •-Normal chest X-ray PA view
- •-Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol
- •-Able and willing to complete the high-fat high-calorie breakfast required for the study
排除标准
- •-Personal/family history of allergy or hypersensitivity to P2202 or related drugs or any of the excipients
- •-Past history of anaphylaxis or angioedema, bronchial asthma and peptic ulcer
- •-Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- •-Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT) etc.
- •-Any cardiac, renal or liver impairment, any other organ or system impairment
- •-History of seizure or psychiatric disorders
- •-Presence of disease markers of HIV 1 and 2, HBsAg and hepatitis C virus
- •-Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit]
- •-Consumption of xanthine-containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours prior to the check-in of each period
- •-Use of any recreational drug or a history of drug addiction
- •-Participation in any clinical trial within the past 3 months
- •-Inaccessibility of veins in left and right arm
- •-Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
- •-Use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks
- •-An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to receiving any study medication and throughout subject?s participation in the study
- •-Consumption of grapefruit-containing food or beverages within 7 days prior to receiving the first dose of study medication in both periods
- •-Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to the study
- •-Volunteers, who observe religious fasting.
研究者
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