🇺🇸 FDA
Pipeline program

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.

Phase 1 other active

Quick answer

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. for 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, cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals. is a Phase 1 program (other) at s.r.o. with 1 ClinicalTrials.gov record(s).

Program details

Company
s.r.o.
Indication
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, cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals.
Phase
Phase 1
Modality
other
Status
active

Clinical trials