Jenkins, Helen
Jenkins, Richard
Patat, Alain
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of Multiple Oral Doses of the Potent CYP3A4 Inhibitor Clarithromycin on the Pharmacokinetics of a Single Oral Dose of Vonoprazan: A Phase I, Open-Label, Sequential Design Study
https://doi.org/10.1007/s40261-016-0488-6
Funding for this research was provided by:
Takeda Pharmaceutical Company Limited
Article History
First Online: 7 December 2016
Compliance with Ethical Standards
:
: This study was conducted in accordance with the Declaration of Helsinki and International Conference of Harmonization—Good Clinical Practice, and all applicable local laws and regulations, between August and September 2010 at the Biotrial study site (Clinical Pharmacology Unit), Rennes, France. The study was authorized by the French Medicine Agency and approved by the Investigational Review Board, the Comité de Protection des Personnes—Ouest VI (Brest, France). All subjects provided written informed consent prior to the initiation of study procedures.
: This study was funded in full by Takeda Pharmaceutical Company Limited. Medical writing assistance was provided by Jordana Campbell, BSc, and Tania Dickson, PhD, of ProScribe—part of the Envision Pharma Group, and was funded by Takeda Pharmaceutical Company Limited. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).
: Helen Jenkins and Richard Jenkins are employees of Takeda Pharmaceutical Company. Alain Patat is employed by Biotrial, who conducted the study on behalf of Takeda Pharmaceutical Company. All authors contributed to the study design, data analysis, writing, and critical review of the manuscript. Takeda Pharmaceutical Company Limited was involved in the study design, data collection, data analysis, and preparation of the manuscript.