NCT05558462

Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers

A Randomized, Open-label, Cross-over Study in Two Periods and Two Sequences to Evaluate the Comparative Pharmacokinetics and Bioavailability of XC8, 10 mg Film-coated Tablets, and XC8, 40 mg Film-coated Tablets, When Taken Once in Equal Doses (40 mg) on an Empty Stomach in Healthy Volunteers

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

Summary

Comparative study of the pharmacokinetics of XC8, film-coated tablets, 10 mg and XC8, film-coated tablets, 40 mg, when administered once in equal doses (40 mg) on an empty stomach in healthy volunteers.

Conditions

• Influenza
• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	XC8	A single dose of R or T drug in each of 2 periods of the study in fasted conditions

Timeline

• Start date: 2022-08-22
• Primary completion: 2022-11-11
• Completion: 2022-12-07
• First posted: 2022-09-28
• Last updated: 2023-10-10

Locations

1 site across 1 country: Russia