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Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers

NCT06096571 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-29

No results posted yet for this study

Summary

1. Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis;
2. Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.
3. To conclude on the bioequivalence of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.

Conditions

  • Viral Infection COVID-19

Interventions

DRUG

Aterixen

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
2024-06-15
Primary Completion
2024-12-15
Completion
2024-12-30

Countries

  • Russia

Study Locations

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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 NCT06096571 on ClinicalTrials.gov