Bioequivalence of Amoxicillin and Clavulanic Acid 875 mg/125 mg Film-Coated Tablets in Healthy Participants Under Fed Conditions.
Phase 1
Recruiting
- Conditions
- o medical condition.Therapeutic area: Not possible to specify
- Registration Number
- CTIS2024-513752-15-00
- Lead Sponsor
- Bial Portela & Ca S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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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How does the fed state influence the pharmacokinetic profile of amoxicillin-clavulanate 875/125 mg film-coated tablets in Phase I trials?
What are the key molecular interactions between amoxicillin and clavulanic acid in Bial Portela & Ca S.A.'s CTIS2024-513752-15-00 formulation under fed conditions?
Which biomarkers correlate with enhanced bioavailability of β-lactam/β-lactamase inhibitor combinations in healthy volunteers?
What adverse events are reported for amoxicillin-clavulanate 875/125 mg film-coated tablets in Phase I studies under fed conditions?
How does Bial's formulation compare to other amoxicillin-clavulanate combinations in terms of β-lactamase inhibition efficacy under fed states?