Clinical trial • Phase III • Other
sodium alginate; calcium carbonate; sodium bicarbonate
Phase III trial of sodium alginate; calcium carbonate; sodium bicarbonate. 16 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 18-12-2025
- First CTIS Authorization Date
- 02-02-2026
Trial design
Phase III trial across 1 site in Portugal.
- Target Sample Size
- 16
Eligibility
Recruits 16 isVulnerablePopulationSelected = true; clinicalTrialGroups include Healthy volunteers. No further details on consent or assent handling provided in source..
- Vulnerable Population
- isVulnerablePopulationSelected = true; clinicalTrialGroups include Healthy volunteers. No further details on consent or assent handling provided in source.
Recruitment
- Planned Sample Size
- 16
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 16
Portugal
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 112
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Miguel Souto
- Contact Person Email
- phase1@blueclinical.pt
- Number Of Participants
- 16
Sponsor
Primary sponsor
- Full Name
- Laboratorios Liconsa S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Medicated chewing gum with sodium alginate, calcium carbonate and sodium bicarbonate
- Active Substance
- sodium alginate; calcium carbonate; sodium bicarbonate
- Modality
- Other
- Routes Of Administration
- oral (chewing gum/buccal)
- Route
- oral (chewing gum)
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