Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
Condition: Bioequivalence; Healthy Japanese Subjects; Pharmacokinetics
Intervention: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water; Ticagrelor OD tablet (90 mg single dose) administered without water; Ticagrelor IR tablet (90 mg) administered with 150 mL of water
Intervention description: Ticagrelor 90 mg OD tablet, single dose; Ticagrelor 90 mg OD tablet, single dose; Ticagrelor 90 mg IR tablet, single dose
Intervention MeSH terms: Ticagrelor
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ticagrelor orodispersible tablet; ticagrelor immediate-release tablet; bioequivalence; Phase I; healthy Japanese subjects

Summary:

      This study will be an open-label, randomised, three-period, three-treatment, crossover study
      in healthy Japanese male and female of non-childbearing potential subjects, performed at a
      single study centre.

      The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD)
      tablets when administered with water and without water and ticagrelor immediate-release (IR)
      tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects aged 20 to 45 years with suitable veins for
             cannulation or repeated venepuncture.

          -  Be Japanese. Japanese is defined as having both parents and four grandparents who are
             Japanese. This includes second and third generation Japanese whose parents or
             grandparents are living in a country other than Japan.

          -  Females must have a negative pregnancy test at screening and on each admission to the
             clinical unit, must not be lactating, and must be of non-childbearing potential,
             confirmed at screening by fulfilling one of the following criteria:

               -  Postmenopausal defined as amenorrhea for at least 12 months or more following
                  cessation of all exogenous hormonal treatments and FSH levels in the
                  postmenopausal range.

               -  Documentation of irreversible surgical sterilization by hysterectomy, bilateral
                  oophorectomy or bilateral salpingectomy but not tubal ligation.

          -  Have a body mass index (BMI) between 18.0 and 27.0 kg/m2 inclusive and weigh at least
             45 kg and no more than 85 kg inclusive.

          -  Be able and willing to communicate with the investigator and comply with all study
             procedures, including reproductive restrictions.

        Exclusion Criteria: - History of any clinically significant disease or disorder which, in
        the opinion of the investigator, may either put the potential subject at risk because of
        participation in the study, or influences the results or the potential subject's ability to
        participate in the study.

          -  Current smokers or those who have smoked or used nicotine products within the previous
             3 months.

          -  History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other
             diseases/syndromes that can either alter or increase the propensity for bleeding.

          -  A personal history of vascular abnormalities including aneurysms; a personal history
             of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe
             thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 1 year prior to
             screening; or history suggestive of peptic ulcer disease; or at the discretion of the
             investigator.

          -  History of a clinically significant non-traumatic bleed or clinically significant
             bleeding risk, as judged by the investigator.

          -  Use of aspirin, ibuprofen, non-steroidal anti-inflammatory drugs (NSAIDs), or any
             other drug known to increase the propensity for bleeding for 2 weeks before
             randomization.

          -  Platelet count less than 150 x 10^9/L.