Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and
      providing evidence for clinical study and clinical application of this product.
    

Detailed description: 
      This is a Single center, randomized, open labeled study. The study is conducted to evaluate
      the pharmacokinetics Studies of Azilsartan with single-dose oral administration,
      multiple-dose oral administration and effects of diet.

      1) Pharmacokinetics Studies of Azilsartan with Single-dose oral administration: 24 healthy
      subjects will be randomly divided into 2 groups evenly, Group I and Group II, with 12
      subjects in each group, half are male and half are female. Group I will take Azilsartan
      tablet 20mg orally on fasting, while Group II will take Azilsartan tablet 40mg orally on
      fasting. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5,
      3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital
      vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be
      taken and kept in low temperature.

      2）Pharmacokinetic Studies of Azilsartan Tablets with Multiple-dose oral administration
      Subjects in Group I will take 20mg Azilsartan orally once daily for 7 day (day 3~day 9) after
      completing the last time blood sample collection (in day 2, 48h) of the first time
      administration (day 1). 5mL blood sample will be collected from vein on day 7, day 8 and day
      9 for measuring minimum observed concentration before drug administration. On day 9, after
      administration, blood sampling time is the same as single-dose administration study. Blood
      sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8,
      10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be
      placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and
      kept in low temperature.

      3）The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in
      single-dose administration study), after 7-day washout period after the first administration
      (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8, and the
      blood sampling time point after administration is the same as in single-dose administration
      study. The process, storage condition of the blood samples are the same as single-dose
      administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1,
      1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood
      from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A
      and B will be taken and kept in low temperature.
    

Intervention name(s): 20mg Azilsartan Tablets; 40mg Azilsartan Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Strength: 20mg, oral administration 1 tablet/ day; Strength: 40mg, oral administration 1 tablet/ day
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment