EUCTR2005-001252-21-DE进行中（未招募）不适用
An open-label, multiple-dose study to evaluate the pharmacokinetics, safety and tolerability of SPP100 (Aliskiren) and Atenolol (Tenormin®) administered alone and in combination in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and/or female subjects from 18-45 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •2.Female subjects must have been surgically sterilized at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
- •Female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom.
- •Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. Menopause will be confirmed by a plasma FSH level of >40 IU/L.
- •3.Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges:
- •- oral body temperature between 35.0-37.5 °C
- •- systolic blood pressure, 120-140 mm Hg
- •- diastolic blood pressure, 70-90 mm Hg
- •- pulse rate, 60 - 90 bpm
- •Blood pressure and pulse will be taken again in a standing position. After 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure associated with clinical manifestation of postural hypotension.
- •4.Body Mass Index (BMI) must be within the range of 18 to 29.9 kg/m2. For instructions and tables see Part B, Section 8.6. Subjects must weigh at least 50 kg for participate in this study.
- •5.Able to provide written informed consent prior to study participation.
- •6.Subject information and consent forms generated by the investigator must be approved by the sponsor prior to submission to the Ethics Committee (EC)/Institutional Review Board (IRB). A copy of the subject information and consent forms approved by the EC/IRB must be forwarded to the sponsor prior to study initiation.
- •7.Able to communicate well with the investigator and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
- •1.Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects using a semi-quantitative test with a cut-off level of 500 ng/mL. All values above will be considered positive. Smokers will be defined as any subject who reports cigarette use or has a positive urine cotinine test.
- •2.Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
- •3.Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •4.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •5.Significant illness within the two weeks prior to dosing.
- •6.A past medical history of clinically significant ECG abnormalities or a history of or family history of long QT syndrome.
- •7.History of autonomic dysfunction.
- •8.History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
- •9.History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drugs or drugs similar to the study drug.
- •10.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following:
- •- history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
- •- history of major gastrointestinal tract surgery such as gastrectomy, gastroentero-stomy, or bowel resection;
- •- history or clinical evidence of pancreatic injury or pancreatitis;
- •- clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. SGPT will have to be strictly within the normal range before inclusion, GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
- •- history or presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria);
- •- evidence of urinary obstruction or difficulty in voiding at screening;
- •- polymorphonuclears <1500/µL or platelets <100’000/µL at inclusion.
- •11.History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- •12.A positive Hepatitis B surface antigen (HBsAg), Anti HBs and Anti-HBc or Hepatitis C test result.
- •13.History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the pharmacokinetics, safety and tolerability of upadacitinib in pediatric subjects with severe atopic dermatitisEUCTR2018-004409-17-NOAbbVie Deutschland GmbH & Co. KG32
进行中（未招募）
1 期
A study to evaluate the pharmacokinetics, safety and tolerability of upadacitinib in pediatric subjects with severe atopic dermatitisSevere Atopic DermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2018-004409-17-NLAbbVie Deutschland GmbH & Co. KG32
进行中（未招募）
1 期
Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)Polyarticular Course Juvenile Idiopathic ArthritisMedDRA version: 20.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2018-000715-25-HUAbbVie Deutschland GmbH & Co. KG54
进行中（未招募）
1 期
Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)Polyarticular Course Juvenile Idiopathic ArthritisMedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2018-000715-25-DEAbbVie Deutschland GmbH & Co. KG124
招募中
1 期
Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)Polyarticular Course Juvenile Idiopathic ArthritisMedDRA version: 21.0Level: PTClassification code: 10059176Term: Juvenile idiopathic arthritis Class: 100000004859CTIS2023-505060-11-00AbbVie Deutschland GmbH & Co. KG124