CRS Clinical Research Services Mannheim GmbH (CRS Clinical Research Services Mannheim GmbH)

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项与 CRS Clinical Research Services Mannheim GmbH 相关的临床试验

Epidemiological evaluation of different biological markers for the classification of non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatohepatitis (NASH) in obese participants with or without Type 2 diabetes

开始日期2019-07-08

申办/合作机构

CRS Clinical Research Services Mannheim GmbH

NCT00711607 / Completed临床1期

A Combined Multiple Dose and Single Dose Trial to Assess the Pharmacokinetic Profile of NOMAC, E2 and E1 After Oral Administration of NOMAC-E2 in Healthy Female Volunteers

The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2

开始日期2007-05-01

申办/合作机构

Organon & Co.

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100 项与 CRS Clinical Research Services Mannheim GmbH 相关的临床结果

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0 项与 CRS Clinical Research Services Mannheim GmbH 相关的专利（医药）

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41

项与 CRS Clinical Research Services Mannheim GmbH 相关的文献（医药）

2024-10-01·Naunyn-Schmiedeberg's Archives of Pharmacology

Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials

Article

作者: Schulze, Friedrich ; Giessmann, Thomas ; Wong, Diane ; Bauer, Verena ; Seitz, Friedeborg

AbstractThis study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509 after oral single rising doses (SRDs) or multiple rising doses (MRDs) in healthy volunteers. In the SRD trial (NCT02694354; February 29, 2016), within each of the three dose groups (DGs), six subjects received BI 685509 (1.0, 2.5, or 5.0 mg) and two received placebo (N = 24). In the MRD trial (NCT03116906; April 17, 2017), within each of the five DGs, nine subjects received BI 685509 (uptitrated to 1 mg once daily [qd; DG1], 2.5 mg twice daily [DG2], 5.0 mg qd [DG3]; 3.0 mg three times daily [tid; DG4] or 4.0 mg tid [DG5]) and three received placebo, for 14–17 days (N = 60). In the SRD trial, 7/24 subjects (29.2%) had ≥ 1 adverse event (AE), most frequently orthostatic dysregulation (n = 4). In the MRD trial, 26/45 subjects (57.8%) receiving BI 685509 had ≥ 1 AE, most frequently orthostatic dysregulation and fatigue (each n = 12). Tolerance development led to a marked decrease in orthostatic dysregulation events (DG3). BI 685509 was rapidly absorbed after oral administration, and exposure increased in a dose-proportional manner after single doses. Multiple dosing resulted in near–dose-proportional increase in exposure and limited accumulation. BI 685509 pharmacokinetics appeared linear with time; steady state occurred 3–5 days after each multiple-dosing period. Increased plasma cyclic guanosine monophosphate and decreased blood pressure followed by a compensatory increase in heart rate indicated target engagement. BI 685509 was generally well tolerated; orthostatic dysregulation may be appropriately countered by careful uptitration.

2024-09-01·Journal of Diabetes Science and Technology

Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes

Article

作者: Waldenmaier, Delia ; Eichenlaub, Manuel ; Vogt, Gerhard ; Freckmann, Guido ; Angstmann, Michael ; Rieger, Cosima C. ; Mueller, Katrin ; Mader, Julia K. ; Mueller-Hoffmann, Wiebke ; Forst, Thomas

Background: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated. Methods: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days. During four in-clinic visits, frequent comparison measurements with capillary blood glucose (BG) samples were performed. The primary endpoint was the 20/20 agreement rate (AR): the percentage of CGM readings within ±20 mg/dL (at BG values <100 mg/dL) or ±20% (at BG values ≥100 mg/dL) of the comparator. Further evaluations included mean absolute relative difference (MARD) and 20/20 AR in different BG ranges and across the wear time. Results: Data from 48 participants and 139 sensors were analyzed. During in-clinic sessions the 20/20 AR was 90.5% and the MARD was 9.2%. For BG ranges <70, 70-180, and >180 mg/dL, 20/20 AR was 94.3%, 89.0%, and 92.5%, respectively. At the beginning, middle, and end of sensor wear time, 20/20 AR was 92.8%, 91.5%, and 85.9%, respectively. The 14-day survival probability was 82.4%. Pain and bleeding after sensor insertion were within the expected range. Based on the study outcome, the use of the device is regarded as safe. Conclusions: The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.

2024-05-01·Diabetes aktuell

Notwendigkeit einer gezielten Risikostratifizierung und konsequenten Behandlung