CTRI/2009/091/000173已完成1 期
A Single-Blind, Randomized, Placebo Controlled, Rising Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of RBx 10017609 in Healthy Adult Male Human Volunteers
Ranbaxy Laboratories Ltd. Plot No. 20, Sector 18 Udyog Vihar Industrial Area Gurgaon 122015. Haryana INDIA0 个研究点目标入组 42 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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 males in the age range of 18 ? 45 years with Body Mass Index (BMI*) between 19 ? 28 kg/m2.
- •?Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
- •?Have voluntarily given written informed consent to participate in this study.
- •?Be of normal health as determined by medical history, have sitting systolic blood pressure of ≥ 100 mmHg to < 140 mmHg and diastolic blood pressure of ≥ 60 mmHg or < 90 mmHg, pulse rate ≥60 & ≤ 90 bpm, clinical examination and laboratory investigations performed within 21 days prior to the commencement of the study.
- •*BMI = Body Weight (in kg)/ Height (in m2)
- •Additional Inclusion criteria for healthy smokers
- •?Current smoker and smoking history of at least 5 pack years.*
- •?No history of cough with sputum production, dyspnoea especially with exercise and wheezing.
- •?No history of respiratory or allergic disease.
- •?Normal baseline spirometry as predicted for age, sex and height.
- •?No history of upper respiratory tract infection in the preceding six weeks.
- •?Not taking regular medication.
- •* 1 pack year is 20 cigarettes/day for 1 year
排除标准
- •?History of hypersensitivity to any drug or history of allergic reactions/atopy.
- •?Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •?Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or venereal infection.
- •?Presence of values, which are out of acceptable limits for hemoglobin, RBC count, hematocrit, activated partial thromboplastin time (aPTT), prothrombin time (PT), total white blood cells count, differential WBC count or platelet count.
- •?Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- •?Presence of values which are out of acceptable limits for blood urea nitrogen (BUN), serum creatinine, uric acid, sodium, potassium, calcium, phosphorus, chloride, bicarbonate, alkaline phosphatase (ALP), aspartate amino transferase (AST), alanine amino transferase (ALT), total bilirubin, gamma glutamyl transpeptidase (GGT), albumin, globulin, total protein, cholesterol, triglycerides, lactate dehydrogenase (LDH), creatine phosphokinase (CPK), glucose, Cystatin C and C-reactive protein.
- •?Clinically abnormal chemical and microscopic examination of urine.
- •?Clinically abnormal ECG (12 lead), QTc >440 msec and abnormal Chest X-ray.
- •?History of or any complaints suggestive of gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, vision abnormality, rheumatological, urogenital or hematological disease.
- •?Presence of significant infection or known inflammatory process.
- •?Presence of acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heart burn).
- •?Presence of chronic constipation (less than 3 times a week for 12 weeks) at the time of screening and/or admission.
- •?Inability to communicate well with investigator (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide, written informed consent.
- •? History of joint pain, stiffness and reduced mobility
- •?Use of tobacco in any form (including cigarette smoking) in the last 6 months (except for healthy smoker cohorts).
- •?History of drug dependence or habitual alcohol abuser.
- •?Use of any regular medication (OTC or prescription) with in 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study.
- •?History of intake of chronic medication.
- •?Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- •?Volunteers who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
研究者
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