drugset / Trial / NCT05294250

Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets

NCT05294250 ↗

Phase 1 Completed 24 enrolled Valenta Pharm JSC
RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective of the study: evaluation of the effect of food intake on the bioavailability of XC8, film-coated tablets, 10 mg after a single oral administration in fed or fasted condition at a dose of 20 mg (two tablets). Additional objective of the study: evaluation of pharmacokinetic parameters, safety and tolerability of XC8, film-coated tablets, 10 mg in healthy volunteers after single oral administration in fed or fasted condition in a dose of 20 mg (two tablets).

Timeline

Start
2022-02-01
Primary completion
2022-02-03
Completion
2022-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject XC8 Unknown 20 mg Oral

Indications

No indication recorded.