ACTRN12610000894099尚未招募1 期
Realtive Bioavailability and pharmacokinetic profiling of a generic darifenacin formulation [Darisec(R - registered trademark) extended release 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg] in healthy fed volunteers
Center for Clinical Pharmacology Research Bdbeq S.A.0 个研究点目标入组 24 人开始时间: 2010年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Educational / counselling / training
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy caucasian male or female subjects 18 to 50 years of age (inclusive)
- •In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician.
- •Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed.
- •Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.
排除标准
- •Known hypersensitivity or severe adverse event to darifenacin or similar drugs.
- •Urinary retention, narrow-angle glucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon.
- •Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (>2 days in a week), severe constipation, gastrointestinal obstructive disorder, and gastric retention.
- •Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
- •Acute or chronic bronchospastic disease (including athma and Chronic Obstructive Pulmonary Disease).
- •Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
- •Smokers of more than 5 cigarettes a week.
- •Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration.
- •Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study.
- •Immunodeficiency diseases, including a positive HIV (Elisa or Western blot) test result.
- •Positive hepatitis B Surface antigen (HBsAg) or Hepatitis C test result.
- •Drug or alcohol abuse within the 6 months prior to dosing.
- •Use of prescription drugs within 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
- •Participation in any clinical investigation within 4 weeks prior to dosing.
- •Donation or loss of 400 ml or more of blood within 2 months prior to dosing.
- •Significant illness within 2 weeks prior to dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
不适用
Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart following Subcutaneous Insulin Infusion (CSII) - Basal Rate Resolution.Type 1 diabetes mellitusContinious subcutaneous insulin infusion (CSII)MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2007-001912-21-DKAarhus Sygehus, Universityhospital of Aarhus
进行中（未招募）
不适用
Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart administered in the Duodenum in healthy volunteers – an open single blinded and uncontrolled exploratory trialDiabetes MellitusEUCTR2006-002803-15-DKAarhus Sygehus12
进行中（未招募）
1 期
A study in healthy volunteers to assess how the test medicine ODM-111 is taken up, broken down and removed from the body when taken by mouth as a tablet, and when given radiolabelled in the form of an oral solution and by short infusion into a veiISRCTN12728443Orion Corporation (Finland)8
已完成
1 期
Comparative Bioavailability of Smartech 2% Sodium Diclofenac Topical Solution and PENNSAID 2% Applied to the Knees of Healthy Male and Female SubjectsOsteoarthritisACTRN12622001391763Avance Clinical Pty Ltd32
进行中（未招募）
1 期
Relative bioavailability and comparative pharmacokinetics (blood levels of the drug) of 13-CRA oral liquid and capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in children requiring treatment cycles of 13-CRA.euroblastomaMedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10029212 Term: Nervous system neoplasms malignant NEC System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: HLGT Classification code 10029211 Term: Nervous system neoplasms malignant and unspecified NEC System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-005104-25-GBova BioPharma Limited20