Clinical trial • Phase II • Infectious Disease
Maribavir for Cytomegalovirus (CMV) infection
Phase II trial of Maribavir for Cytomegalovirus (CMV) infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Cytomegalovirus (CMV) infection
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-10-2025
- First CTIS Authorization Date
- 02-02-2026
Trial design
Randomised, open-label, maribavir tablets 200 mg (sun pharmaceutical industries limited) versus livtencity® (maribavir) coated tablets 200 mg (catalent cts, llc / packed by takeda ireland limited) — single-dose, crossover, fasting condition-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Maribavir Tablets 200 mg (Sun Pharmaceutical Industries Limited) versus LIVTENCITY® (Maribavir) Coated Tablets 200 mg (Catalent CTS, LLC / packed by Takeda Ireland Limited) — single-dose, crossover, fasting condition
- Crossover
- Yes
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected: true; groups: Healthy volunteers. No information provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected: true; groups: Healthy volunteers. No information provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 40
Romania
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 111
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Terapia S.A. (Strada Fabricii Nr. 124, Cluj-Napoca)
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
- Number Of Participants
- 40
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Maribavir Tablets 200 mg (manufactured by Sun Pharmaceutical Industries Limited)
- Active Substance
- Maribavir
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- Oral
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg (single dose)
- Frequency
- Single-dose
- Maximum Dose
- 200 mg
- Investigational Product Name
- LIVTENCITY® (Maribavir) Coated Tablets 200 mg (reference product; manufactured by Catalent CTS, LLC; packed by Takeda Ireland Limited)
- Active Substance
- Maribavir
- Modality
- Small molecule
- Routes Of Administration
- Oral (coated tablets)
- Route
- Oral
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg (single dose)
- Frequency
- Single-dose
- Maximum Dose
- 200 mg
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