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2/17/2023 7:45:24 AM | Browse: 277 | Download: 841
Publication Name World Journal of Pharmacology
Manuscript ID 80095
Country India
Received
2022-09-16 12:47
Peer-Review Started
2022-09-16 12:49
To Make the First Decision
Return for Revision
2022-10-31 01:17
Revised
2022-11-11 11:27
Second Decision
2023-02-07 03:30
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief
2023-02-07 06:24
Articles in Press
2023-02-07 06:24
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript
2023-02-08 08:36
Publish the Manuscript Online
2023-02-17 07:04
ISSN 2220-3192 (online)
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: http://creativecommons.org/Licenses/by-nc/4.0/
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Article Reprints For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
Permissions For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
Publisher Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Website http://www.wjgnet.com
Category Pharmacology & Pharmacy
Manuscript Type Randomized Clinical Trial
Article Title Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole
Manuscript Source Unsolicited Manuscript
All Author List Syed Mujtaba Hussain Naqvi, Monil Yogesh Neena Gala, Snehal Muchhala, Anand Arumugam, Dhananjay Panigrahi, Dipak Patil, Rahul Rathod and Amey Mane
Funding Agency and Grant Number
Corresponding Author Monil Yogesh Neena Gala, MBBS, MD, Doctor, Medical Affairs, Dr Reddy’s Laboratories, Dr Reddy's Laboratories Ltd, Global Generics- India, 7-1-27, Ameerpet, Hyderabad 500016, Telangana, India. monil.yogesh@drreddys.com
Key Words Supra-Bioavailable itraconazole; Conventional itraconazole; Oral bioavailability; Pharmacodynamics; Efficacy; Adverse events
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.
Publish Date 2023-02-17 07:04
Citation Naqvi SMH, Gala MYN, Muchhala S, Arumugam A, Panigrahi D, Patil D, Rathod R, Mane A. Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole. World J Pharmacol 2023; 12(1): 1-11
URL https://www.wjgnet.com/2220-3192/full/v12/i1/1.htm
DOI https://dx.doi.org/10.5497/wjp.v12.i1.1
Full Article (PDF) WJP-12-1.pdf
Full Article (Word) WJP-12-1.docx
Manuscript File 80095_Auto_Edited-JLW.docx
Answering Reviewers 80095-Answering reviewers.pdf
Audio Core Tip 80095-Audio core tip.m4a
Biostatistics Review Certificate 80095-Biostatistics statement.pdf
Clinical Trial Registration Statement 80095-Clinical trial registration statement.PDF
Conflict-of-Interest Disclosure Form 80095-Conflict-of-interest statement.pdf
Copyright License Agreement 80095-Copyright license agreement.pdf
Signed Informed Consent Form(s) or Document(s) 80095-Informed consent statement.pdf
Institutional Review Board Approval Form or Document 80095-Institutional review board statement.pdf
Non-Native Speakers of English Editing Certificate 80095-Language certificate.pdf
Peer-review Report 80095-Peer-review(s).pdf
Scientific Misconduct Check 80095-Bing-Ma YJ-2.jpg
Scientific Editor Work List 80095-Scientific editor work list.pdf