Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Pharmacol. Feb 17, 2023; 12(1): 1-11
Published online Feb 17, 2023. doi: 10.5497/wjp.v12.i1.1
Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole
Syed Mujtaba Hussain Naqvi, Monil Yogesh Neena Gala, Snehal Muchhala, Anand Arumugam, Dhananjay Panigrahi, Dipak Patil, Rahul Rathod, Amey Mane
Syed Mujtaba Hussain Naqvi, Monil Yogesh Neena Gala, Snehal Muchhala, Rahul Rathod, Amey Mane, Medical Affairs, Dr Reddy’s Laboratories, Hyderabad 500016, India
Anand Arumugam, Dipak Patil, Global Clinical Management, Dr Reddy’s Laboratories, Hyderabad 500016, India
Dhananjay Panigrahi, Formulation Development, Dr Reddy’s Laboratories, Hyderabad 500016, India
Author contributions: Syed N, Monil G, Snehal M, Anand A, Dhananjay P, Dipak P, Rahul R, Amey M equally contributed to this work; designed research; performed research; analyzed data and drafted the paper; all authors provided critical feedback and helped shape the research, analysis, and manuscript.
Institutional review board statement: The study protocol, informed consent forms and other relevant documents (subjects’ accrual) were reviewed and approved by ‘Ethicare Ethics committee’. Pre-screening and general safety instructions in view of COVID-19 pandemic were reviewed and approved by ‘Human Care Independent Ethics Committee’. The study was performed in compliance with the principles of the Declaration of Helsinki for Medical Research involving human subjects, the Guideline for Good Clinical Practice and Drug Control General of India regulatory guidelines.
Clinical trial registration statement: This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki [Ethical Principles for Medical Research Involving Human Subjects, Revised by 71th WMA General Assembly at Cordoba, Spain (virtual), in 2020] and that were consistent with Good Clinical Practices and Drug Control General of India regulatory guidelines.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report that they are employees of Dr Reddy’s Laboratories Ltd. The authors report no other conflicts of interest in this work.
Data sharing statement: The datasets are available only on request due to privacy/ethical restrictions.
CONSORT 2010 statement: The authors have read and filled out the CONSORT Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Monil Yogesh Neena Gala, MBBS, MD, Doctor, Medical Affairs, Dr Reddy’s Laboratories, Dr Reddy's Laboratories Ltd, Global Generics, 7-1-27, Ameerpet, Hyderabad 500016, Telangana, India. monil.yogesh@drreddys.com
Received: September 16, 2022
Peer-review started: September 16, 2022
First decision: October 31, 2022
Revised: November 11, 2022
Accepted: February 7, 2023
Article in press: February 7, 2023
Published online: February 17, 2023
Processing time: 153 Days and 18.3 Hours
Core Tip

Core Tip: Itraconazole, a triazole antifungal with a broad spectrum, has a nonlinear pharmacokinetic profile due to its variable oral bioavailability. Based on these criteria, a comparison of Fixtral SB (supra bioavailable itraconazole) 100 mg with Lozanoc capsules 50mg administered as two capsules was performed, revealing that Fixtral SB is expected to have therapeutically comparable efficacy at half the equivalent dose. In terms of area under the concentration-time curve/minimum inhibitory concentration, the pharmacodynamic activity of the test product at 100 mg dose and the marketed itraconazole 200 mg is comparable. All of the formulations tested were found to be safe and well tolerated, with manageable side effects.