Search Results - "Wensing, Georg"

Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 : an oral, direct Factor Xa inhibitor-after multiple dosing in healthy male subjects by KUHITZA, Dagmar, BECKA, Michael, WENSING, Georg, VOITH, Barbara, ZUEHLSDORF, Michael

“…There is a clinical need for safe new oral anticoagulants. The safety, tolerability, pharmacodynamics, and pharmacokinetics of BAY 59-7939--a novel, oral,…”
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Pharmacokinetics, safety and tolerability of the novel, selective mineralocorticoid receptor antagonist finerenone - results from first-in-man and relative bioavailability studies by Lentini, Silvia, Heinig, Roland, Kimmeskamp-Kirschbaum, Nina, Wensing, Georg

“…The safety, tolerability and pharmacokinetics of the selective nonsteroidal mineralocorticoid receptor antagonist finerenone were evaluated in healthy male…”
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First Assessment in Humans of the Safety, Tolerability, Pharmacokinetics, and Ex Vivo Pharmacodynamic Antimalarial Activity of the New Artemisinin Derivative Artemisone by NAGELSCHMITZ, Johannes, VOITH, Barbara, WENSING, Georg, ROEMER, Axel, FUGMANN, Burkhard, HAYNES, Richard K, KOTECKA, Barbara M, RIECKMANN, Karl H, EDSTEIN, Michael D

“…Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit…”
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Single-Dose Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of the Soluble Guanylate Cyclase Stimulator BAY 63-2521: An Ascending-Dose Study in Healthy Male Volunteers by Frey, Reiner, Mück, Wolfgang, Unger, Sigrun, Artmeier-Brandt, Ulrike, Weimann, Gerrit, Wensing, Georg

“…The aim of the study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 63–2521, a new drug in development for pulmonary…”
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Assessment of the Effects of Hepatic Impairment and Smoking on the Pharmacokinetics of a Single Oral Dose of the Soluble Guanylate Cyclase Stimulator Riociguat (BAY 63-2521) by Frey, Reiner, Becker, Corina, Unger, Sigrun, Schmidt, Anja, Wensing, Georg, Mück, Wolfgang

“…Riociguat, a soluble guanylate cyclase stimulator developed for the treatment of pulmonary hypertension, is metabolized in part by the liver. Expression of one…”
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Assessment of the Effects of Renal Impairment and Smoking on the Pharmacokinetics of a Single Oral Dose of the Soluble Guanylate Cyclase Stimulator Riociguat (BAY 63-2521) by Frey, Reiner, Becker, Corina, Unger, Sigrun, Schmidt, Anja, Wensing, Georg, Mück, Wolfgang

“…Renal impairment is a common comborbidity in patients with pulmonary hypertension. The breakdown of riociguat, an oral soluble guanylate cyclase stimulator…”
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Bioavailability, Pharmacokinetics, and Safety of Riociguat Given as an Oral Suspension or Crushed Tablet with and without Food by Saleh, Soundos, Frey, Reiner, Becker, Corina, Unger, Sigrun, Wensing, Georg, Mück, Wolfgang

“…Riociguat is approved for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Some patients have difficulty…”
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Riociguat (BAY 63-2521) and Aspirin: A Randomized, Pharmacodynamic, and Pharmacokinetic Interaction Study by Frey, Reiner, Reber, Michael, Krätzschmar, Jörn, Unger, Sigrun, Mück, Wolfgang, Wensing, Georg

“…In preclinical studies, drugs that increase cyclic guanosine monophosphate levels have been shown to influence platelet function/aggregation; however, the…”
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Pharmacokinetic Interaction Study between Riociguat and the Combined Oral Contraceptives Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women by Frey, Reiner, Unger, Sigrun, van der Mey, Dorina, Becker, Corina, Saleh, Soundos, Wensing, Georg, Mück, Wolfgang

“…Female patients requiring treatment for pulmonary arterial hypertension (PAH) are advised to avoid pregnancy because of the high associated mortality rate…”
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Variability in clinical chemistry parameters in healthy male volunteers prior to drug administration, an overview of Bayer in-house phase I trials from 2000 - 2013 INSERT TABLE AST and γGT values are less affected. Conclusion: A 24h predose lab sample may by Wensing, Georg

“…Abstract only…”
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Safety of healthy subjects in first-in-human multiple-dose studies: A pooled analysis by Jung, David, Braun, Inka Valeska, Wensing, Georg

“…Reflecting the extended scope of the valid EMA regulation, this analysis intends to contribute to the knowledge about risk for participants in first-in-human…”
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Pharmacodynamic Effects of an Angiotensin II Receptor-Antagonist in Phase I—Comparison between Healthy Subjects and Patients with Hypertension by Wensing, Georg, Ochmann, Klaus, Boettcher, Michael, Schäfer, Anja, Kuhlmann, Jochen

“…Biomarkers are increasingly used to provide decision making data early in phase I by showing Proof of Mechanism or Proof of Concept (PoM/PoC). For…”
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Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor by Kubitza, Dagmar, Becka, Michael, Voith, Barbara, Zuehlsdorf, Michael, Wensing, Georg

“…Background and Objective There is a clinical need for new oral anticoagulants to prevent and treat thromboembolic diseases. Given its integral role in the…”
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Cinaciguat (BAY 58―2667) Improves Cardiopulmonary Hemodynamics in Patients With Acute Decompensated Heart Failure by LAPP, Harald, MITROVIC, Veselin, FRANZ, Norbert, HEUER, Hubertus, BUERKE, Michael, WOLFERTZ, Judith, MUECK, Wolfgang, UNGER, Sigrun, WENSING, Georg, FREY, Reiner

“…Cinaciguat (BAY 58-2667) is the first of a new class of soluble guanylate cyclase activators in clinical development for acute decompensated heart failure. We…”
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How safe are our studies? Analysis of adverse events in Bayer First-in-Human trials from 2006 to 2016 by Jung, David, Boettcher, Michael-Friedrich, Wensing, Georg

“…In regard to the current scientific discussion, this analysis aims to broaden the database for a risk evaluation of First-in-Human (FiH) trials with healthy…”
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First in Human (FiH) studies in healthy volunteers – a 10 years review by Jung, David, Mueck, Wolfgang, Wensing, Georg

“…Abstract only…”
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Riociguat (BAY 63-2521) and Warfarin: A Pharmacodynamic and Pharmacokinetic Interaction Study by Frey, Reiner, Mück, Wolfgang, Kirschbaum, Nina, Krätzschmar, Jörn, Weimann, Gerrit, Wensing, Georg

“…Riociguat (BAY 63–2521) and warfarin are likely to be used concomitantly to treat pulmonary hypertension. The aim of this double‐blind, crossover, clinical…”
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Visual event-related P300 potentials in early portosystemic encephalopathy by Kügler, C F, Lotterer, E, Petter, J, Wensing, G, Taghavy, A, Hahn, E G, Fleig, W E

“…Visual event-related P300 potentials, conventional visual evoked potentials, and psychometric tests were applied to patients with noncirrhotic chronic liver…”
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Who is a ‘healthy subject’?—consensus results on pivotal eligibility criteria for clinical trials by Breithaupt-Groegler, Kerstin, Coch, Christoph, Coenen, Martin, Donath, Frank, Erb-Zohar, Katharina, Francke, Klaus, Goehler, Karin, Iovino, Mario, Kammerer, Klaus Peter, Mikus, Gerd, Rengelshausen, Jens, Sourgens, Hildegard, Schinzel, Reinhard, Sudhop, Thomas, Wensing, Georg

“…Introduction/Methods A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key…”
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The applications of biomarkers in early clinical drug development to improve decision-making processes by Kuhlmann, Jochen, Wensing, Georg

“…Selecting, evaluating and applying biomarkers in drug discovery and exploratory drug development do substantially shorten the time to reach a critical decision…”
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