DRKS00015049
Completed
未知
A single-center, open pilot trial to investigate the performance of the modified intravascular microdialysis probe MicroEye® in healthy subjects - iCGM_01
A. Menarini Diagnostics S.r.l.0 sites20 target enrollmentAugust 8, 2018
ConditionsHealthy Subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Healthy Subjects
- Sponsor
- A. Menarini Diagnostics S.r.l.
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed consent obtained after being advised of the nature of the study
- •2\. Male or female aged 18 \- 75 years (both inclusive)
- •3\. Healthy volunteer
- •4\. Body mass index 20\.0 \- 29\.5 kg/m² (both inclusive)
- •5\. Availability of veins (within the forearms) suitable for insertion of three intravenous lines (two for microdialysis sampling and one for reference blood withdrawal).
Exclusion Criteria
- •1\. Female of childbearing potential who is pregnant, breast\-feeding or intending to become pregnant or is not using adequate contraceptive methods
- •2\. Skin pathology or condition prohibiting needle insertion as judged by the Investigator
- •3\. History of bleeding disorder
- •4\. History of heparin\-induced thrombocytopenia (HIT)
- •5\. Current participation in another clinical study
- •6\. Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the Investigator
- •7\. Drugs which have an influence on glucose metabolism such as: systemic (oral or i.v.) corticosteroids, anticoagulation medication, monoamine oxidase (MAO) inhibitors or paracetamol. Thyroid hormones are not allowed unless the use of these has been stable during the past 1 month.
- •8\. Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day
- •9\. Known hypersensitivity to Fondaparinux sodium (Arixtra ®)
- •10\. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A single center, open, pilot study to evaluate the pharmacokinetic profile of a new galenic formulation of an Ambroxol-Hydrochloride (Ambroxol-HCl) spray: Ambroxol CYATHUS” 50 mg/mL Oral Spray, administered in a single dose of 30 mg Ambroxol-HCl to healthy male volunteersMedDRA version: 8.1Level: LLTClassification code 10006440Term: Bronchial obstructionEUCTR2006-005291-41-ATCYATHUS Exquirere PharmaforschungsGmbH
Completed
Not Applicable
Study to measure the direct portal vein pressure gradient in patients with liver diseaseISRCTN11916601Kantonsspital St. Gallen18
Completed
Not Applicable
A single centre, open label trial investigating the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjectsgroeihormoondeficientiegrowth hormone deficiencyNL-OMON42854ovo Nordisk A/S7
Active, not recruiting
Phase 1
A pilot study to assess the efficacy and safety of CBD oral solution in addition to standard treatment for pediatric subjects with Developmental and Epileptic EncephalopathyDevelopmental and Epileptic Encephalopathy (DEE)MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2019-001633-14-ITIRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA20
Active, not recruiting
Not Applicable
An open monocentric pilot study to investigate the potential of imiquimod 5% cream to detect residual and to prevent recurrence of lentigo maligna after surgical excisioAn open monocentric pilot study to investigate the potential of imiquimod 5% cream to detect residual and to prevent recurrence of lentigo maligna after surgical excisionEUCTR2010-019422-13-ATMedical University of Graz