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

NCT05558462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-10

No results posted yet for this study

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

Interventions

DRUG

XC8

A single dose of R or T drug in each of 2 periods of the study in fasted conditions

Sponsors & Collaborators

  • Valenta Pharm JSC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2022-11-11
Completion
2022-12-07

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558462 on ClinicalTrials.gov