CTRI/2009/091/000914招募中1 期
A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Bristol-Myers Squibb Research and Development311 Pennington-Rocky Hill RoadPennington, NJ 085340 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
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) Signed Written Informed Consent
- •a) The signed informed consent form.
- •2) Target Population
- •a) Healthy Indian subjects as determined by no clinically significant deviation from
- •normal in medical history, physical examination, ECGs, and clinical laboratory
- •determinations.
- •b) Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive.
- •BMI = weight (kg)/ [height (m)]2.
- •3) Age and Sex
- •a) Indian men and postmenopausal women (non-child bearing potential) ages
- •18 to 55 years of age inclusive
排除标准
- •Sex and Reproductive Status
- •a) Women of child bearing potential (WOCBP):
- •WOCBP include any female who has experienced menarche and is not
- •postmenopausal.
- •Postmenopause is defined as:
- •? Amenorrhea ≥12 consecutive months without another cause and a
- •documented serum FSH level >35 mIU/mL
- •? Women with irregular menstrual periods and a documented serum FSH level
- •>35 mIU/mL
- •? Women on HRT
- •Women who are using oral contraceptives, other hormonal contraceptives
- •(vaginal products, skin patches, or implanted or injectable products), or
- •mechanical products such as an intrauterine device or barrier methods
- •(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing
- •abstinence or where their partner is sterile (eg, vasectomy) should be considered
- •to be of childbearing potential.
- •b) Premenopausal women including surgically sterile women having undergone a
- •hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
- •c) Women with a positive pregnancy test on enrollment or prior to administration of
- •investigational product.
- •d) Women who are pregnant or breastfeeding
- •e) Sexually active fertile men not using effective birth control (double barrier) if
- •their partners are WOCBP.
- •2) Medical History and Concurrent Diseases
- •a) At risk for tuberculosis (TB) infection. Specifically subjects with:
- •i) Current clinical, radiographic or laboratory evidence of active or latent TB
- •ii) A history of active TB within the last 3 years, even if it was treated.
- •iii) A history of active TB greater than 3 years ago unless there is documentation
- •that the prior anti-TB treatment was appropriate in duration and type.
研究者
相似试验
尚未招募
3 期
Concomitant Administration of the Methylphenidate and AmantadineIRCT20130310012776N7Shiraz University of Medical Sciences200
招募中
2 期
Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of laborextended pregnancies.Obstructed labor, unspecifiedO66.9IRCT20181123041731N2Mashhad University of Medical Sciences74
已完成
2 期
Efficacy of concomitant administration of nebulized lasix and salbutamol on spirometric indices of asthmatic patientsAsthma.Asthma, unspecifiedIRCT201104136187N1Vice chancellor for research, Kashan University of Medical Sciences54
进行中（未招募）
不适用
The effect of the co-administration of multiple oral doses of the fructose-1,6-bisphosphatase (FBPase) inhibitor CS-917 and glibenclamide on pharmacokinetics, safety and tolerability in diabetic patients (NIDDM) - Not availableDiabetes mellitus type 2EUCTR2004-003195-11-DESankyo Pharma GmbH
已完成
不适用
The effects of the simultaneous administration of transtracheal block and tropical anesthesia of glossopharyngeal nerve on hemodynamic change during intubation in awake patients with laryngeal cancerIRCT20220518054912N1Tehran University of Medical Sciences60