ISRCTN20012465已完成1 期
Pharmacokinetics study of a single bolus intravenous injection of diclofenac sodium solution administered in male and female healthy volunteers: single dose, open-label, four-part pharmacokinetic study.
IBSA Biochemical Institute (Institut Biochimique) S.A.0 个研究点目标入组 53 人开始时间: 2015年12月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
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
- 性别
- All
入选标准
- •1. Informed consent
- •2. Females and males, 18-55 years old inclusive
- •3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- •4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
- •5. Females of child-bearing potential using reliable methods of contraception
- •6. Females of non-child-bearing potential or in post-menopausal status for at least 1 year
- •7. For all female subjects, pregnancy test result must be negative at screening
排除标准
- •1. ECG 12-leads (supine position): clinically relevant abnormalities
- •2. Clinically relevant abnormal physical findings
- •3. Clinically relevant abnormal laboratory values
- •4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients or other non-steroidal anti-inflammatory drugs (NSAIDs); history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study. History of asthma
- •5. Relevant history of significant renal, hepatic, gastrointestinal (in particular active or suspected gastrointestinal ulcers or bleeding), genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study. History of haemorrhagic diathesis, thalassemia, sickle-cell disease, G6PD deficiency and any other condition that could potentially lead to haemolysis
- •6. Intake of medications, including over-the-counter (OTC) medications and herbal products for 2 weeks before the start of the study. In particular NSAID or anticoagulant use for 2 weeks before and during the entire study. Hormonal contraceptives for females are allowed
- •7. Participation in the evaluation of any investigational product in the 3 months before this study
- •8. Blood donations in the 3 months before this study
- •9. History of drug, alcohol [> 1 drink/day for females and >2 drinks/day for males, defined according to USDA Dietary Guidelines 2010 (8)], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day)
- •10. Positive result at the drug test at screening
- •11. Positive alcohol breath test
- •12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •13. Positive or missing pregnancy test at screening or day -1, pregnant or lactating women
研究者
相似试验
已完成
不适用
A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT)Refractory hematologic disorders, including 1. Acute myelogenous leukemia 2. Acute lymphoblastic leukemia 3. Myelodysplastic syndrome 4. Chronic myelogenous leukemia 5. Malignant lymphoma 6. Aplastic anemiaJPRN-UMIN000004264Kobe University Graduate School of Medicine10
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-CZMundipharma Research Limited28
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaEUCTR2008-002219-42-ATMundipharma Research Limited28
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-NLMundipharma Research Limited28
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-GBMundipharma Research Limited28