CTRI/2009/091/000749已完成1 期
A Single-Blind, Randomized, Placebo Controlled, Single Dose Safety, Tolerability and Pharmacokinetic Study of RBx 10017609 in Elderly Male and Female Subjects
Ranbaxy Laboratories Ltd0 个研究点目标入组 24 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
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Elderly male and female subjects (post menopausal) > 65 years of age with a BMI* in the range of 18-29 kg/m2, inclusive.
- •* BMI = Body weight (in kg)/ Height (in m2)
- •2.Medical history, physical examination, vital signs, clinical laboratory tests and 12-lead ECG without significant abnormalities in the opinion of the investigator.
- •3.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.
- •4.Willingness to give written informed consent (prior to any study related procedure being performed) and ability to adhere to the study restrictions and assessment schedule.
- •5.Negative urinary drugs of abuse test, alcohol breath test and cotinine urine test (at screening and admission day).
- •6.For Postmenopausal women
- •1. Last menstrual period (LMP) equal to or more than 1 year or surgical hysterectomy.
- •2. Endocrine status matching post menopausal women as confirmed by Serum FSH levels or ultrasound only in doubtful cases.
排除标准
- •1.Any known history of hypersensitivity.
- •2.Any evidence of organ dysfunction or any clinically relevant abnormal physical finding at the screening assessment.
- •3.Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or venereal infection.
- •4.Clinically significant abnormalities in the results of the clinical laboratory tests (at screening).
- •5.Positive for urinary drugs of abuse test, alcohol breath test and cotinine urine test (at screening and at admission).
- •6.Systolic blood pressure <90 mmHg or 140 mmHg or diastolic blood pressure <50 mmHg or ≥90 mmHg or pulse rate <45 bpm or >100 bpm, or postural drop in blood pressure from supine to standing of >20 mmHg (systolic) or >10 mmHg (diastolic) at screening.
- •7.Clinical relevant abnormalities in 12-lead ECG including QTc >440 msec, and abnormal chest X-Ray.
- •8.History of or any complaints suggestive of clinically significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, significant visual impairment, rheumatological, urogenital or haematological disease.
- •9.Presence of significant infection or known inflammatory process.
- •10.History of joint pain or stiffness or other causes leading to significant immobility.
- •11.Presence of any surgical or medical condition which in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the study drug or might be likely to compromise the safety of the subject.
- •12.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.
- •13.Use of tobacco in any form (including cigarette smoking) in the last 6 months.
- •14.History of drug dependence or habitual alcohol abuse.
- •15.History of chronic intake of medication.
- •16.Intake of any medication (OTC or prescription) within 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study.
- •17.Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- •18.Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in last 3 months.
- •19.Positive urine pregnancy test at the time of screening (for females only).
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