Assessment of QTc-prolonging potential of BX471 in healthy volunteers. A 'thorough QTc study' following ICH E14 using various QT correction methods

British Journal of Clinical Pharmacology

Volumn 68, Issue 3, 2009, Pages 435-446

  Vandemeulebroecke, Marc ^a   Lembcke, Jürgen ^a   Wiesinger, Herbert ^a   Sittner, Wolfgang ^a   Lindemann, Stefanie ^a  

^a BAYER PHARMA AG   (Germany)

Author keywords

BX471; ECG; Electrocardiography; QT; QTc; Thorough QT study

Indexed keywords

1 [5 CHLORO 2 [2 [4 (4 FLUOROBENZYL) 2 METHYL 1 PIPERAZINYL] 2 OXOETHOXY]PHENYL]UREA; MOXIFLOXACIN; PLACEBO;

ABDOMINAL DISCOMFORT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; FEMALE; HEART CONDUCTION; HEART PALPITATION; HEART VENTRICLE EXTRASYSTOLE; HUMAN; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL ANALYSIS; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NAUSEA; PRACTICE GUIDELINE; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUPRAVENTRICULAR PREMATURE BEAT; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADMINISTRATION, ORAL; ADULT; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HEART RATE; HUMANS; MALE; MIDDLE AGED; PHENYLUREA COMPOUNDS; PIPERIDINES; RECEPTORS, CHEMOKINE; YOUNG ADULT;

EID: 69949141680     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03460.x     Document Type: Article

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