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Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions

NCT05339373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-06-28

No results posted yet for this study

Summary

This is an open-label, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Airtal ®, 100 mg film-coated tablets) or the test (Aceclofenac, 100 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Conditions

  • Bioequivalence

Interventions

DRUG

Aceclofenac film-coated tablet 100 mg

Aceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac.

DRUG

Airtal® film-coated tablet 100 mg

Airtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac.

Sponsors & Collaborators

  • X7 Clinical Research LLC

    collaborator UNKNOWN

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Evgenia Simonova · CRO X7 Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2022-04-30
Completion
2022-08-15

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 NCT05339373 on ClinicalTrials.gov