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Randomized, open-label, replicated single-dose, 4-period, 2-sequence crossover study to assess the comparative bioavailability of test product Amlodipine/Valsartan/Hydrochlorothiazide 10 mg/160 mg/12.5 mg film-coated tablets to reference product Exforge HCT 10 mg/160 mg/12.5 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
CTIS2025-523054-14-00
Enrollment
42
Registered
2025-08-28
Start date
2025-09-15
Completion date
2025-12-09
Last updated
2025-12-02

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)

Interventions

None listed

Sponsors

Pharma Start LLC
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