A Randomized, Open-Label, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Maribavir 200 mg in Healthy Adult Subjects Under Fasting Conditions

This study is a bioequivalence investigation designed to compare the pharmacokinetic profiles of Maribavir 200 mg tablets manufactured by Sun Pharmaceutical Industries Limited with the reference product LIVTENCITY® (Maribavir) 200 mg coated tablets. The primary objective is to evaluate the bioequivalence of these two formulations in healthy adult subjects under fasting conditions to ensure therapeutic interchangeability. The study focuses on determining whether the test product demonstrates equivalent systemic exposure to the reference product.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 64 years. Both males and females are included in the cohort. The participants are being evaluated in the context of cytomegalovirus infection or disease that is refractory to prior therapies following hematopoietic stem cell transplantation or solid organ transplantation.

This bioequivalence study is designed as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover trial. The research objective is to compare Maribavir 200 mg tablets manufactured by Sun Pharmaceutical Industries Limited with LIVTENCITY 200 mg coated tablets manufactured by Catalent CTS, LLC. The investigation will be conducted in healthy adult human subjects under fasting conditions. The methodology involves a sequential administration of both treatments to allow for intra-subject comparison. The study period is estimated to occur between March 2026 and September 2026.

Efficacy assessment in this study focuses on patients with refractory cytomegalovirus infection or disease following hematopoietic stem cell transplantation or solid organ transplantation. Evaluation is conducted within the framework of a Phase 2 clinical trial.