A Single Dose, Fed state, Crossover Replicate Bioequivalence Study of NITROFURANTOIN 100 mg prolonged-release capsules (Iasis Pharma) vs. FURABID® 100 mg prolonged-release capsules (Amdipharm Limited)
Phase 1
- Conditions
- healthy subjectsTherapeutic area: Diseases [C] - Male Urogenital Diseases [C12]Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-503887-18-00
- Lead Sponsor
- Antibiotice S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
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