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1.
Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies.
Br J Clin Pharmacol
; 83(8): 1815-1825, 2017 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-28230262
2.
A phase I, randomized, proof-of-clinical-mechanism study assessing the pharmacokinetics and pharmacodynamics of the oral PDE9A inhibitor BI 409306 in healthy male volunteers.
Hum Psychopharmacol
; 32(1)2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-28120486
3.
Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.
Lancet
; 386(9994): 680-90, 2015 Aug 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-26088268
4.
First-in-human study assessing safety, tolerability and pharmacokinetics of BI 409306, a selective phosphodiesterase 9A inhibitor, in healthy males.
Br J Clin Pharmacol
; 82(5): 1315-1324, 2016 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-27378314
5.
Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment.
Antimicrob Agents Chemother
; 59(1): 251-7, 2015 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-25348520
6.
Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF).
Expert Opin Biol Ther
; : 1-7, 2024 May 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-38739422
7.
Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial.
Lancet Gastroenterol Hepatol
; 6(10): 816-825, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-34388360
8.
Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study.
Eur J Drug Metab Pharmacokinet
; 43(2): 239-249, 2018 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-29076028
9.
Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics.
Clin Drug Investig
; 38(8): 737-750, 2018 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-29846887
10.
The Renal Elimination Pathways of the Dabigatran Reversal Agent Idarucizumab and its Impact on Dabigatran Elimination.
Clin Appl Thromb Hemost
; 24(5): 724-733, 2018 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-29534609
11.
Similar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials.
Rheumatol Ther
; 5(2): 403-421, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29959660
12.
The safety, tolerability and pharmacokinetics of BI 409306, a novel and potent PDE9 inhibitor: Overview of three Phase I randomised trials in healthy volunteers.
Eur Neuropsychopharmacol
; 28(5): 643-655, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29567399
13.
Evaluation of Pharmacokinetics and Pharmacodynamics of BI 425809, a Novel GlyT1 Inhibitor: Translational Studies.
Clin Transl Sci
; 11(6): 616-623, 2018 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-30136756
14.
Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study.
Clin Pharmacokinet
; 56(1): 41-54, 2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27317414
15.
Idarucizumab does not have procoagulant effects: Assessment of thrombosis biomarkers in healthy volunteers.
Thromb Haemost
; 117(2): 269-276, 2017 01 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-27904905
16.
Measurement of dabigatran plasma concentrations by calibrated thrombin clotting time in comparison to LC-MS/MS in human volunteers on dialysis.
Thromb Res
; 135(3): 532-6, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25600440
17.
A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran.
Thromb Haemost
; 113(5): 943-51, 2015 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-25789661
18.
Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal disease.
Thromb Haemost
; 109(4): 596-605, 2013 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-23389759
19.
Restarting Dabigatran Etexilate 24 h After Reversal With Idarucizumab and Redosing Idarucizumab in Healthy Volunteers.
J Am Coll Cardiol
; 67(13): 1654-1656, 2016 04 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-27150693
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