Randomized, Open-label, Single-Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Amoxicilin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL to Augemntin ES 600 mg/42.9 mg/5 mL powder for oral suspension in Healthy Adult Male and Female Volunteers under Fed Conditions.
Phase 1
- Conditions
- ot applicable (submitted trial is a bioequivalence study in healthy subjects).MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumonia Class: 10021881Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2023-503233-22-00
- Lead Sponsor
- Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
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
- Secondary Outcome Measures
Name Time Method