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Article History

Received: 24 March 2026

Accepted: 3 June 2026

First Online: 1 July 2026

Declarations

Conflict of interest: All authors are full-time employees of Sun Pharmaceutical Industries Limited.

Ethics approval: The study was conducted at a single center in accordance with the ethical principles of the Declaration of Helsinki and applicable regulatory requirements. The study protocol was reviewed and approved on 10 October 2021 by the Jamia Hamdard Institutional Ethics Committee (JHIEC; Registration no. ECR/48/Inst/DL/2013/RR-22). The study was not prospectively registered in a clinical trial registry.

Consent to participate: All subjects signed the informed consent form prior to commencement of the study.

Consent for publication: All authors have reviewed and approved the final version of the manuscript.

Availability of data and material: The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Author contributions: Sudershan Kumar and Arshad Khuroo contributed to the pharmacokinetic and statistical investigation, including protocol design and determination of study endpoints. Sanjay Jagannath Gurule and Hari Krishan Tiwari responsible for the bioanalytical investigation. Sachin Mehra served as clinical investigator and was involved in the conduct of the clinical study. Y. Zala, Venkata Rama Rao Kamala, and Madhu Kandukuri contributed to formulation development. Shruti Dharmadhikari, Prashant Devkare, and Chintan Khandhedia contributed to drafting of the manuscript, critical revision for important intellectual content, and data visualization. All authors reviewed and approved the final version.

Code Availability: Statistical analyses were performed using validated SAS ® software procedures in accordance with US-Food and Drug Administration (FDA) recommendations. No custom code was generated for this study.