Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence,
      two-period, crossover, comparative study, where each subject was randomly assigned to the
      reference or the test formulation in each period of the study (sequences RT or TR), in order
      to evaluate if both formulations are bioequivalent.The study was conducted in multiple
      groups.
    

Detailed description: 
      The objective of this study is to establish if two formulations of sotalol are bioequivalent.
      The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference
      formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany). 36
      healthy adult volunteers of both genders with age ranging from 18 to 55 years old will
      receive a single tablet (160 mg of sotalol) of the test and the reference products with 200
      ml of water after an overnight fast of at least 10 hours, according to the pre-defined
      randomization list. In the first period, 18 subjects will receive the test product and 18
      subjects the reference product.In the second period subjects will receive the products in the
      opposite order. Subjects will fast 4 hours after administration of the study drugs during
      each study period. Standardized meals will be provided in each study period. Water will not
      be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours
      after administration of the study drugs in each period. In each period blood samples were
      collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24;
      36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A
      validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte
      (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t
      and 90% confidence interval will be constructed for the ratio of geometric least square means
      of the test and the reference products, obtained from the log-transformed data.
      Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval
      for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and
      AUC0-t.
    

Intervention name(s): Sotalol; Sotalex
Intervention type(s): Drug; Drug
Intervention description(s): Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus; Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH & Co. KGaA, Germany
Other intervention name(s): the test product; the reference product
Intervention MeSH terms: Sotalol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Bioequivalence; Sotalol; Sotalex