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Article History

Received: 21 January 2025

Accepted: 14 September 2025

First Online: 12 November 2025

Declarations

:

: All authors are employees of Sun Pharma, that sponsored the study.

: The study protocol, Subject Information Sheet and Informed Consent Form (SIS-ICF), Investigational Product (IP) Information and other protocol-related documents were approved by Conscience Independent Ethics Committee in the meeting held on 24 Aug 2020. The study was conducted in compliance and accordance with the ethical principles that have their origins in the Declaration of Helsinki, Good Clinical Practice, New Drugs and Clinical trials Rules, 2019, Ministry of Health and Family Welfare, Government of India, CDSCO Guidelines for Bioavailability & Bioequivalence Studies Mar 2005, Indian Council of Medical Research (Ethical Guidelines for Biomedical Research on Human Participants, 2017), Guideline on the Investigation of Bioequivalence (European Medicines Agency, London, 20 January 2010, CPMP/EWP/QWP/1401/98 Rev 1) and other applicable regulatory requirements. In order to achieve and comply with the ethical principles mentioned in the above guidelines: clinical monitoring was performed; integrity of data was maintained during its generation and only quality assurance approved data were used for estimation of pharmacokinetic (PK) parameter and assessment of safety in the present study.

: All the subjects signed an informed consent form (ICF) before participating in the study.

: Data related to findings of the study can be obtained from the corresponding author upon reasonable request subject to confidentiality obligations. Patient-related data may be further subjected to patient confidentiality and may not be available to the public.

: The study participants provided their consent for publication of the data. No individual subject identifiable data are included in the manuscript.

: Not applicable.

: S.K. designed the protocol and endpoints for the study and contributed as pharmacokinetic and statistical investigator, S.J.G. contributed as bioanalytical investigator, A.K. managed the study, S.S., A.T., A.S., and S.B. were involved in formulation development, A.S. and S.B. did formulation review, P.D., S.D., and C.K. contributed to data visualization, and were involved in drafting and critical review of the manuscript. All authors read and approved the final version and agree to be accountable for the work.