Clinical trial • Phase I • Other
lidocaine for Healthy volunteers (bioavailability study) | Local anaesthesia
Phase I trial of lidocaine for Healthy volunteers (bioavailability study) | Local anaesthesia.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers (bioavailability study) | Local anaesthesia
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-03-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
open-label, 2% lidocaine gel vs 4% lidocaine gel administered into the urethra-controlled Phase I trial across 1 site in Germany.
- Open Label
- Yes
- Comparator
- 2% lidocaine gel vs 4% lidocaine gel administered into the urethra
- Target Sample Size
- 28
Eligibility
Recruits 28 No vulnerable populations selected; study enrols healthy adult male volunteers only. Consent/assent handling not specified in the available documents..
- Vulnerable Population
- No vulnerable populations selected; study enrols healthy adult male volunteers only. Consent/assent handling not specified in the available documents.
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 28
Germany
- Earliest CTIS Part Ii Submission Date
- 07-04-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 28
Sites
- Site Name
- SocraTec R&D Concepts in Drug Research and Development GmbH
- Department Name
- CPU
- Contact Person Name
- Ulrike Burkhardt
- Contact Person Email
- info@socratec-pharma.de
- Number Of Participants
- 28
Sponsor
Primary sponsor
- Full Name
- Farco-Pharma GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Lidocaine 2% gel (urethral administration)
- Active Substance
- lidocaine
- Modality
- Small molecule
- Routes Of Administration
- Urethral (gel)
- Route
- Urethral
- Starting Dose
- 2% gel
- Dose Levels
- 2%
- Investigational Product Name
- Lidocaine 4% gel (urethral administration)
- Active Substance
- lidocaine
- Modality
- Small molecule
- Routes Of Administration
- Urethral (gel)
- Route
- Urethral
- Starting Dose
- 4% gel
- Dose Levels
- 4%
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