Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is an open-labeled, randomized, two period, crossover, a single-center, comparative,
      single-dose study, in which 36 healthy adult subjects will receive one of the study
      treatments during each study period.

      The objective of this study is to determine the bioequivalence of two different formulations
      of aceclofenac after a single oral dose administration under fasting conditions.

      Subject eligibility for this study will be determined at the screening visit and eligible
      subjects will be admitted to the clinical research unit at least 12 hours prior to drug
      administration for each study period.

      Hospitalization in the first period of the study will last no more than 37 hours, after
      which, in the absence of indications for an extension of hospitalization, each subject will
      be released home; after that, the first period of the study will be completed.

      The procedures of the second study period will be identical to the first period.

      After completing all the procedures of the second study period, each subject will undergo a
      final examination, after which, in case of the absence of adverse events and indications for
      prolonging hospitalization, the study for the subjects will be considered completed.

      The total duration of the study for the subject will be no more than 22 days.

      Eligible subjects will be randomized to one of two treatment sequences. There will be two
      sequences in the study: TR and RT, where T = the test product, R = the reference product.

      For each study period, subjects will receive a single 100 mg oral dose of aceclofenac (the
      test or the reference formulation). Study participants will be aware they will receive
      different formulations of the same drug, without being informed which product (Test or
      Reference) is being administered. For each subject, all scheduled postdose activities and
      assessments will be performed relative to the time of study drug administration.

      Fasting will continue for at least 4 hours following drug administration, after which a
      standardized lunch will be served. Next meals will be provided for subjects in 6 hours, 9
      hours and 12 hours after drug administration.

      Water will be provided as needed until 1 hour predose. Water will be allowed beginning 2
      hours after the administration of the drug.

      A total of 20 blood samples will be collected (one tube of 6 mL each) in each study period
      for pharmacokinetic (PK) assessments. The first blood sample will be collected prior to drug
      administration while the others will be collected up to 24 hours after drug administration.

      Aceclofenac plasma concentrations will be measured according to a validated bioanalytical
      method.

      Statistical analysis of all PK parameters will be based on an ANOVA model. Two-sided 90%
      confidence interval of the ratio of geometric LSmeans obtained from the ln-transformed PK
      parameters will be calculated.

      Statistical inference of aceclofenac will be based on a bioequivalence approach using the
      following standards: the ratio of geometric LSmeans with corresponding 90% confidence
      interval calculated from the exponential of the difference between the Test and the Reference
      for the ln-transformed parameters Cmax and AUC0-t should all be within the 80.00 to 125.00%
      bioequivalence range.
    

Intervention name(s): Aceclofenac film-coated tablet 100 mg; Airtal® film-coated tablet 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): Aceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac.; Airtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac.
Other intervention name(s): The test product; The reference product
Intervention MeSH terms: Aceclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other