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Randomized, open-label, single dose, two-period, cross-over bioequivalence study comparing test formulation Rosuvastatin/Amlodipine/Ramipril capsule, hard 10mg/5mg/5mg versus reference products Crestor 10 mg film coated tablets, Norvasc 5 mg tablets, Tritace 5 mg tablets in healthy male and female subjects under fasting conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503822-38-00
Enrollment
60
Registered
2023-05-16
Start date
2023-06-19
Completion date
2023-08-22
Last updated
2023-07-03

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 a bioequivalence study in healthy subject).

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