Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, randomized, single dose, full replicate, crossover comparative
      laboratory-blinded study will be conducted in healthy male and female volunteers in order to
      determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after
      oral administration under fasting conditions.
    

Detailed description: 
      The study is characterized by single center, randomized, single dose, laboratory-blinded,
      4-period, 2-sequence, full replicate crossover design.The objective is to determine the
      bioequivalence of two different formulations of telmisartan after a single oral dose
      administration under fasting conditions. The test product is Telmisartan 80 mg tablets
      manufactured by Pharmtechnology LLC, Belarus. The reference product is Micardis 80 mg tablets
      manufactured by Boehringer Ingelheim Ellas AE, Greece. The primary study endpoints are the
      pharmacokinetic parameters Cmax and AUC0-T of telmisartan.

      Eligible 26 healthy adult subjects will be randomized to the one of two predetermined
      sequences: ABAB or BABA where A = the test product, B = the reference product. Clinical part
      of the study will include 4 periods; in each of them a single 80 mg dose of telmisartan will
      be administered orally with approximately 240 mL of water, in the morning, following a
      10-hour overnight fast. Wash-out period between treatment administrations will last at least
      14 calendar days.

      Subjects will be confined to the clinical site from at least 10 hours prior to each drug
      administration until 24 hours following each drug administration. Subjects will return to the
      clinical site for the remaining blood samples.

      In each study period, 21 blood samples will be collected for pharmacokinetic assessments. The
      first blood sample will be collected prior to drug administration while the others will be
      collected up to 72 hours after drug administration (0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25,
      1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 postdose)
      .

      Total study duration: up to 74 days (including screening).

      Telmisartan plasma concentrations will be measured by a validated bioanalytical method.

      Statistical analysis of pharmacokinetic parameters will be based on an ANOVA model. Two-sided
      90% confidence interval of the ratio of geometric LSmeans will be obtained from the
      ln-transformed pharmacokinetic parameters.

      Statistical inference of telmisartan will be based on a bioequivalence approach using the
      following standards:

        -  average bioequivalence (the ratio of geometric LSmeans with corresponding 90% confidence
           interval calculated from the exponential of the difference between the test and the
           reference product for the ln-transformed parameters Cmax and AUC0-T should all be within
           the 80.00 to 125.00% bioequivalence range);

        -  scaled-average-bioequivalence (in the event that the Cmax reference-to-reference
           within-subject CV is greater than 30%, that its test-to-reference geometric LSmeans
           ratio is within the bioequivalence range of 80.00 125.00% and the average bioequivalence
           criteria are not met, a scaling approach to the bioequivalence assessment will be used).
    

Intervention name(s): Telmisartan; Micardis
Intervention type(s): Drug; Drug
Intervention description(s): Telmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan.; Micardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan.
Other intervention name(s): the test product; the reference product
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In compliance with full replicate design there are two sequences in the study: ABAB and BABA where A = the test product, B = the reference product (see detailed description of items below).
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: telmisartan; bioequivalence; Micardis