NCT05294250

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

An Open-label, Randomized, Cross-over Study With 2 Treatments (Fasting and After Meals), 3 Periods, 2 Sequences, and an Adaptive, Two-stage Design to Evaluate the Effect of Food Intake on the Bioavailability of XC8, Film-coated Tablets, 10 mg at a Single Dose of 20 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	XC8	XC8 10 mg film-coated tablets, 3 discrete doses of 20 mg each separated by 7-day wash-out periods

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-02-03
• Completion: 2022-02-26
• First posted: 2022-03-24
• Last updated: 2023-07-27

Locations

1 site across 1 country: Russia