Shennak, Mustafa http://orcid.org/0000-0002-3508-9522
Al-Jaouni, Rana
Kshirasagar, Santhosh
Kasibhatta, Ravi Sekhar
Godse, Neelima
Al-Ghazawi, Ahmad
Vittala, Praveen
Bakhle, Dhananjay
Article History
First Online: 14 March 2020
Compliance with Ethical Standards
:
: Funding for the phase 1 study was provided by Lupin Ltd. Editorial assistance was provided under the direction of the authors by The Lynx Group LLC. Funding support for the manuscript was provided by Mylan Inc.
: Mustafa Shennak is employed as Principal Investigator at Triumpharma. Rana Al-Jaouni is employed as Chief Operating Officer at Triumpharma. Santhosh Kshirasagar is employed as Assistant Director at Lupin Bioresearch Center in the Biopharmaceutics Department. Ravi Sekhar Kasibhatta is employed as Senior Vice President at Lupin Bioresearch Center. Neelima Godse is employed as a Research Scientist in the Medical Research Department of Lupin Limited (Research Park). Ahmad Al-Ghazawi is employed as President and Chief Executive Officer at Triumpharma. Praveen Vittala is employed as Assistant Director at Lupin Bioresearch Center in the Bioanalytic Research Department. Dhananjay Bakhle is employed as Executive Vice President—Medical Research, Lupin Limited.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board of Triumpharma and were conducted in accordance with international clinical research guidelines and the principles enunciated in the 1964 Declaration of Helsinki and its later amendments, Good Clinical Practice, the Committee for Medicinal Products for Human Use guideline on the investigation of bioequivalence, and the local regulations and laws set by the Jordan Food and Drug Administration. The protocol of the study was approved by the IRB and the Ethical Committee of Triumpharma Research Institution of Amman, Jordan. The unique Jordan Food & Drug Administration trial number is 31/Clinical/2018.
: Written informed consent was obtained from all individual participants included in the study.
: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.