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2/17/2023 7:45:24 AM | Browse: 422 | Download: 1582
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Received |
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2022-09-16 12:47 |
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Peer-Review Started |
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2022-09-16 12:49 |
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To Make the First Decision |
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Return for Revision |
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2022-10-31 01:17 |
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Revised |
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2022-11-11 11:27 |
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Second Decision |
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2023-02-07 03:30 |
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Accepted by Journal Editor-in-Chief |
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Accepted by Executive Editor-in-Chief |
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2023-02-07 06:24 |
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Articles in Press |
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2023-02-07 06:24 |
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Publication Fee Transferred |
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Edit the Manuscript by Language Editor |
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Typeset the Manuscript |
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2023-02-08 08:36 |
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Publish the Manuscript Online |
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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
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Permissions |
For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
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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
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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 |
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Corresponding Author |
Monil Yogesh Neena Gala, MBBS, MD, Doctor, 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 |
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