Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
Condition: Rhinitis
MeSH terms: Rhinitis
Intervention: Levocetirizine IRT 5 mg; Levocetirizine ODT 5 mg
Intervention description: Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Intervention MeSH terms: Cetirizine; Levocetirizine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral disintegrating tablet; Levocetirizine; Immediate release tablet; Bioequivalence; Japanese subjects

Summary:

      This study will be an open-label, randomized 2-way cross-over study to evaluate
      bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese
      male subjects. Approximately 48 subjects will participate in this study to receive a single
      dose treatments of levocetirizine ODT 5 milligram (mg) or levocetirizine IRT 5 mg. In Part 1,
      subjects will randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single
      dose of levocetirizine ODT 5 mg with water or single dose levocetirizine IRT 5 mg with water
      in fasted state. In this part, comparison of bioavailability of levocetirizine ODT and
      levocetirizine IRT when taken with water in the fasted state will be assessed. In Part 2,
      subjects will be randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive
      single dose levocetirizine ODT 5 mg without water or single dose levocetirizine IRT 5 mg with
      water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT
      without water and levocetirizine IRT with water in the fasted state will be assessed. There
      will be at least a 5-day wash out period between the intervention periods. The duration of
      each subject's participation in each part will be approximately 7 weeks from screening to
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 20 to 55 years of age inclusive, at the time of signing the informed
             consent.

          -  Japanese subjects who are overtly healthy as determined by medical evaluation
             including medical history, physical examination, laboratory tests, and cardiac
             monitoring.

          -  Subjects with body weight of >= 50 kilogram (kg) and body mass index (BMI) within the
             range of >=18.5 and <25.0 kg per meter square (m^2).

          -  In male subjects contraceptive use should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

          -  Male subjects are eligible to participate if they agree to the following during the
             intervention period and until the completion of follow-ups: Refrain from donating
             sperm; Be abstinent from heterosexual or homosexual intercourse as their preferred and
             usual lifestyle (abstinent on a long term and persistent basis) and agree to remain
             abstinent; Agree to use a male condom and female partner to use an additional highly
             effective contraceptive method with a failure rate of <1 percentage per year when
             having sexual intercourse with a woman of childbearing potential who is not currently
             pregnant; Agree to use male condom when engaging in any activity that allows for
             passage of ejaculate to another person.

          -  Subjects must be non-smokers.

          -  Subjects capable of giving signed informed consent.

        Exclusion Criteria:

          -  Subjects with history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs;
             constituting a risk when taking the study intervention; or interfering with the
             interpretation of data.

          -  Subjects with abnormal blood pressure as determined by the investigator.

          -  Subjects with history of allergic rhinitis.

          -  Subjects with ALT >1.5x upper limit of normal (ULN).

          -  Subjects with bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is
             acceptable if bilirubin is fractionated and direct bilirubin <35 percentage).

          -  Subjects with current or chronic history of liver disease, or known hepatic or biliary
             abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  Subjects with QTc >450 millisecond (msec).

          -  Subjects with past or intended use of over-the-counter or prescription medication
             including vitamins, diet supplements (including St. John's wort), herbal medications
             within 14 days prior to first dosing or 5 half-lives (whichever is longer).

          -  Exposure to more than 4 new chemical entities within 12 months prior to the first
             dosing day.

          -  Current enrolment or past participation within 4 months prior to the first dosing day
             in this or any other clinical study involving an investigational study intervention or
             any other type of medical research (except for the subjects with no study intervention
             administered during any of those enrolment or participation).

          -  The subject with positive serological test for syphilis (Rapid Plasma Reagin [RPR] and
             Treponema pallidum [TP] antibody tests), Human immunodeficiency virus (HIV)
             Antigen/Antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV)
             antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.

          -  Subject with positive pre-study drug screen.

          -  Subject with regular moderate alcohol consumption within 6 months prior to the study
             participation defined as: An average weekly intake of >14 units for males. One unit is
             equivalent to 360 milliliter (mL) of beer, 150 mL of wine or 45 mL of 80 proof
             distilled of spirits.

          -  Smoking or history or regular use of tobacco- or nicotine-containing products within 6
             months prior to screening.

          -  Sensitivity to any of the study interventions, or components thereof, or drug or other
             allergy that, in the opinion of the investigator or Medical Monitor, contraindicates
             participation in the study.

          -  History of donation of blood or blood products >= 400 mL within 3 months or >=200 mL
             within 1 month prior to the first dosing day.