Clinical trial • Phase III • Other
Tadalafil for Healthy volunteers
Phase III trial of Tadalafil for Healthy volunteers.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-03-2026
- First CTIS Authorization Date
- 29-04-2026
Trial design
Randomised, two tadalafil formulations: tadalafil oral suspension, single oral dose 20 mg (fasting) versus tadalafil film-coated tablets, single oral dose 20 mg (fasting).-controlled, crossover Phase III trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Two tadalafil formulations: tadalafil oral suspension, single oral dose 20 mg (fasting) versus tadalafil film-coated tablets, single oral dose 20 mg (fasting).
- Crossover
- Yes
- Target Sample Size
- 8
Eligibility
Recruits 8 No vulnerable populations selected; trial involves healthy adult male volunteers only; no consent/assent details provided..
- Vulnerable Population
- No vulnerable populations selected; trial involves healthy adult male volunteers only; no consent/assent details provided.
Recruitment
- Planned Sample Size
- 8
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 8
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Farmacologia Clinica
- Contact Person Name
- Antonio Portolés Perez
- Contact Person Email
- ufase1fc.hcsc@salud.madrid.org
- Number Of Participants
- 8
Sponsor
Primary sponsor
- Full Name
- Farmalider S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Tadalafil oral suspension
- Active Substance
- Tadalafil
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg (single dose)
- Frequency
- single oral dose
- Maximum Dose
- 20 mg
- Investigational Product Name
- Tadalafil film-coated tablets
- Active Substance
- Tadalafil
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg (single dose)
- Frequency
- single oral dose
- Maximum Dose
- 20 mg
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