Absence of QTc prolongation with domperidone: A randomized, double-blind, placebo- and positive-controlled thorough QT/QTc study in healthy volunteers
Article first published online: 30 MAY 2014
© 2014 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Clinical Pharmacology in Drug Development
Volume 4, Issue 1, pages 41–48, January/February 2015
How to Cite
Biewenga, J., Keung, C., Solanki, B., Natarajan, J., Leitz, G., Deleu, S. and Soons, P. (2015), Absence of QTc prolongation with domperidone: A randomized, double-blind, placebo- and positive-controlled thorough QT/QTc study in healthy volunteers. Clinical Pharm in Drug Dev, 4: 41–48. doi: 10.1002/cpdd.126
- Issue published online: 15 JAN 2015
- Article first published online: 30 MAY 2014
- Accepted manuscript online: 2 APR 2014 05:37AM EST
- Manuscript Accepted: 28 MAR 2014
- Manuscript Received: 9 NOV 2013
- Janssen Pharmaceutica NV
- Janssen Research & Development, LLC
- 1Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007; 102(9):2036–2045., , .Direct Link:
- 2European Medicines Agency. Motilium Summary of Product Characteristics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Motilium/human_referral_000090.jsp&mid=WC0b01ac05805c516f Accessed 23 April 2013.
- 4US Food and Drug Administration. ICH guidance for industry: S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. October 2005. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074963.pdf. Accessed 31 July 2013.
- 7European Medicines Agency. Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/10/WC500117061.pdf Accessed 23 April 2013.
- 8US Food and Drug Administration. ICH guidance for industry: E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. May 2005. Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf Accessed 31 July 2013.
- 9US Food and Drug Administration. Guidance for Industry, Bioanalytical Methods Validation. 2001. Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf Accessed 21 January 2014.