NCT05295121

Study of the Effect of Food Intake on the Bioavailability of XC221 100 mg 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 XC221 100 mg Tablets at a Single Dose 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 XC221 100 mg tablets after a single oral administration in fed or fasted condition. Additional objective of the study: evaluation of pharmacokinetic parameters, safety and tolerability of XC221 100 mg tablets in healthy volunteers after single oral administration in fed or fasted condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	XC221 100 mg tablets	XC221, 3 discrete doses separated by 7-day wash-out periods

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-02-22
• Completion: 2022-03-17
• First posted: 2022-03-24
• Last updated: 2023-07-27

Locations

1 site across 1 country: Russia