Clinical trial • Phase III • Gastroenterology
gaxilose for Hypolactasia
Phase III trial of gaxilose for Hypolactasia. 24 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Hypolactasia
- Trial Stage
- Phase III
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 11-04-2025
- First CTIS Authorization Date
- 22-07-2025
Trial design
Phase III trial in Spain.
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population not selected; participants are healthy adult volunteers; no consent/assent details provided..
- Vulnerable Population
- Vulnerable population not selected; participants are healthy adult volunteers; no consent/assent details provided.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Spain
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 169
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pharmacology Service
- Principal Investigator Name
- Antonio J. Carcas Sansuán
- Principal Investigator Email
- antonio.carcas@uam.es
- Contact Person Name
- Antonio J. Carcas Sansuán
- Contact Person Email
- antonio.carcas@uam.es
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Venter Pharma S.L.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Gaxilose
- Active Substance
- gaxilose
- Modality
- Diagnostic agent
- Routes Of Administration
- oral
- Route
- oral
Related trials
Other published trials that may interest you.