ISRCTN25043983已完成1 期
Pilot tolerability and bioavailability study of a new DHEP medicated plaster, administered at two doses, in comparison with the marketed DHEP medicated plaster (Flector EP Tissugel®)
IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 24 人开始时间: 2021年9月8日最近更新:
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
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Sex and age: males and females, 18-45 years old inclusive
- •3. Body Mass Index (BMI): 18.5-30 kg/m² inclusive
- •4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position
- •5. Full comprehension: the 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
- •6. Contraception and fertility (women only): women of childbearing potential must be using at least one of the following reliable methods of contraception:
- •6.1. Hormonal oral, implantable, intrauterine device [IUD], transdermal or injectable contraceptives for at least 2 months before the screening visit
- •6.2. A non-hormonal IUD or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- •6.3. A male sexual partner who agrees to use a male condom with spermicide
- •6.4. A sterile sexual partner
- •Women of non-childbearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test result must be negative at screening and day -1 of each study period
排除标准
- •1. Electrocardiogram (12-lead, supine position): clinically significant abnormalities
- •2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study and which the investigator considers may affect the outcome of the study
- •3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- •4. Application site: diseased-skin, skin wounds, open injuries or tattoos at the application site
- •5. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •6. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
- •7. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
- •8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- •9. Blood donation (population subgroup for PK analysis only): blood donations for 3 months before this study
- •10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020), or caffeine abuse (>5 cups coffee/tea/day) or tobacco abuse (10 or more cigarettes/day)
- •11. Drug test: positive result at the drug test at screening or day -1
- •12. Alcohol test: positive alcohol breath test at day -1
- •13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •14. Pregnancy (women only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
研究者
相似试验
已完成
1 期
Preliminary study with the aim to assess the effect on humans and the amount of a drug that reaches the blood circulation when using a newly developed plaster containing the painkiller diclofenac in comparison with the marketed diclofenac medicated plaster (Flector EP Tissugel®)Tolerability and bioavailability of a new DHEP medicated plaster versus a market reference formulation on healthy subjectsISRCTN26063832IBSA Institut Biochimique (Switzerland)24
已完成
1 期
Study to assess the distribution in the blood of healthy volunteers of a new formulation of losartan compared with the marketed formulation Cozaar® administered under fasting conditionsBioavailability of a new formulation of losartanISRCTN16928142DPL Pharma S.p.A.16
进行中（未招募）
不适用
A study to compare a pediatric tablet or suspension of elvitegravir verses the adult 150 mg tablet in healthy adult volunteersHuman Immunodeficiency Virus (HIV-1) InfectionMedDRA version: 17.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 100000004862EUCTR2015-000725-37-Outside-EU/EEAGilead Sciences, Inc.78
已完成
不适用
A comparative bioavailability study of a single dose of ziltivekimab formulation B in a manual syringe, formulation D in a manual syringe and formulation C in a pen-injectorCardiovascular diseaseNL-OMON53876ovo Nordisk A/S200
进行中（未招募）
1 期
Evaluation of efficacy and bioavailability of ibuprofen lysinatePain on an inflammatory basis (otitis and otomastoiditis, adenite, cellulite, arthritis) and post-operative painMedDRA version: 21.0Level: PTClassification code 10050533Term: Pain assessmentSystem Organ Class: 10022891 - InvestigationsMedDRA version: 20.1Level: LLTClassification code 10063374Term: Pain scaleSystem Organ Class: 10022891 - InvestigationsEUCTR2019-000647-27-ITDicofarm S.p.A.84