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Randomized, open-label, single dose, three-period, three treatment cross-over bioavailability study comparing test products Rosuvastatin/Ezetimibe, tablets, 20 mg /10 mg or Ezehron Duo, 20 mg + 10 mg, tablet, both administered in combination with Nilemdo 180 mg film-coated tablets to reference products Nustendi 180 mg/10 mg film-coated tablets in combination with Crestor, 20 mg, film-coated tablets in healthy male and female subjects under fasting conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507048-35-00
Acronym
950/23
Enrollment
24
Registered
2023-10-02
Start date
2023-10-11
Completion date
2024-01-04
Last updated
2023-10-02

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

Conditions

not applicable (submitted trial is bioavailability study in healthy subjects)

Interventions

None listed

Sponsors

Adamed Pharma S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

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