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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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503887-18-00
Acronym
NITRAIS 01/2023
Enrollment
32
Registered
2023-07-19
Start date
2023-10-02
Completion date
2023-11-13
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

None listed

Sponsors

Antibiotice S.A., Iasis Pharmaceuticals Hellas S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026