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Clinical Trials in the EU / 2025-523487-21-00
Authorised Phase I

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Maribavir Tablets 200 mg, manufactured by Sun Pharmaceutical Industries Limited, India with LIVTENCITY® (Maribavir) Coated Tablets 200 mg, manufactured by: Catalent CTS, LLC Kansas City, United States of America, packed by: Takeda Ireland Limited Bray, Ireland, imported by: Takeda Pharma Ltda. Highway SP 340 S/N, km 133.5 Jaguariúna Administrative Building -SP CNPJ 60.397.775/0001-74 SAC: 0800 - 7710345, in healthy adult, human subjects under fasting condition.

2025-523487-21-00 · tracked via the Priya Life Science EU tracker
Sponsor
Sun Pharmaceutical Industries Limited
Sponsor type
Pharmaceutical company
Therapeutic area
Virus Diseases
Decision date
02/02/2026
Enrollment target
40
Sites
Romania

Condition studied

cytomegalovirus (CMV) infection and/or disease that is refractory (with or without resistance) to one or more prior therapies in adult patients who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT)

Eligibility

Age group
18-64 years
Sex
Female, Male
Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523487-21-00 on CTIS ↗ ← All trials in the EU