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A pilot, open label, single dose, randomized, four-period, four-sequence, four-treatment crossover, comparative bioavailability study of UDCA PMCS 500 mg formulation 1 film-coated tablets (test 1 formulation), and UDCA PMCS 500 mg formulation 2 film-coated tablets (test 2 formulation), and UDCA PMCS 500 mg formulation 3 film-coated tablets (test 3 formulation), and reference formulation in healthy, male and female volunteers under fasting conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519920-26-00
Enrollment
24
Registered
2025-02-12
Start date
2025-02-20
Completion date
2025-04-14
Last updated
2025-02-12

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

Conditions

cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals., UDCA causes a reduction in cholesterol saturation of the bile by inhibiting cholesterol absorption in the intestine and reducing cholesterol secretion into the bile. Presumably

Interventions

None listed

Sponsors

Cepha s.r.o., PRO.MED.CS Praha a.s.
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