Comparative Bioavailability of Midazolam 7.5 mg/1.5 mL Oromucosal Solution (Buccolam®) Versus 10 mg/2 mL Solution for Injection (Hypnovel®) in Healthy Subjects.
Phase 1
Active, not recruiting
- Conditions
- o medical condition.Therapeutic area: Not possible to specify
- Registration Number
- CTIS2023-504903-10-00
- Lead Sponsor
- aboratorios Lesvi S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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What molecular mechanisms underlie midazolam's bioavailability differences between oromucosal and injectable forms?
How does the pharmacokinetic profile of Buccolam® compare to Hypnovel® in phase I trials for benzodiazepine delivery?
Are there specific biomarkers that correlate with midazolam absorption rates in healthy subjects via different administration routes?
What adverse event management strategies are employed in midazolam formulation trials by Laboratorios Lesvi S.L.?
How does the bioavailability of midazolam oromucosal solutions compare to other benzodiazepines in preclinical and clinical studies?