A Bioequivalence (BE) Study in Healthy Subjects
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: Administered orally, once.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4
      milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per
      capsule) in healthy adult male Japanese subjects.
    

Eligibility criteria:

        Inclusion Criteria

          -  Are healthy Japanese males, as determined by medical history and physical examination

          -  Have a body mass index (BMI) of greater than or equal to 17.6 and less than or equal
             to 26.4 kg/m2 at screening

          -  Cytochrome P450 2D6 (CYP2D6) genotype is categorized as extensive metabolizers (EM)
             from the result of screening test. EM includes Intermediate Metabolizer (IM) and
             Ultrarapid Metabolizer (UM).

          -  Have clinical laboratory test results within normal reference range for the population
             and investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  Have given written informed consent approved by Lilly and the ethical review board
             governing the site before any trial activities

        Exclusion Criteria

          -  Are investigator site personnel directly affiliated with this study and their
             immediate families. Immediate family is defined as a spouse, parent, child or sibling,
             whether biological or legally adopted.

          -  Persons who are employed by the sponsor (that is, employees, temporary contract
             workers, or designees responsible for conducting the study).

          -  Are currently enrolled in, or discontinued within the last 4 months from, a clinical
             trial involving an investigational drug or device, or are concurrently enrolled in any
             other type of medical research judged not to be scientifically or medically compatible
             with this study.

          -  Have known allergies to atomoxetine (LY139603) or related compounds.

          -  Are persons who have ever used atomoxetine, or previously participated in this study
             or any other study investigating atomoxetine and received the study drug.

          -  An abnormality in the 12-lead ECG that in the opinion of the investigator increases
             the risk of participating in the study, such as a corrected QT (QTc) interval >450
             milliseconds (msec).

          -  Subjects with a current or past history of clinically significant elevated blood
             pressure (Supine systolic blood pressure greater than or equal to 140 millimeters of
             mercury [mmHg] or Supine diastolic blood pressure greater than or equal to 90 mmHg)

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, or metabolism or elimination of drugs or of
             constituting a risk when taking the study medication or of interfering with the
             interpretation of data.

          -  Regularly use known drugs of abuse, or show positive findings on urinary drug
             screening.

          -  Have a positive result for Human Immunodeficiency Virus (HIV) test, or show evidence
             of possible infection.

          -  Have a positive result for hepatitis B antigen test, or show evidence of possible
             infection.

          -  Have a positive result for hepatitis C antibody test, or show evidence of possible
             infection.

          -  Have a positive result for syphilis test, or show evidence of possible infection.

          -  Use or intend to use over-the-counter or prescription medication 7 and 14 days,
             respectively prior to dosing.

          -  Blood donation of more than 200 mL of blood and component blood donation within one
             month prior to dosing, or those who have donated more than 400 mL of blood within 3
             month prior to dosing, or history of blood donation of more than 950 mL within the
             last 12 months.

          -  Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling
             to stop alcohol consumption for the duration of the study (1 unit = 360 mL of beer;
             150 mL of wine; 45 mL of distilled spirits).

          -  Subjects with a history of seizure, excluding febrile convulsion in childhood.

          -  Exposure to a monoamine oxidase inhibitor (MAOI) drug or herbal preparations with
             central nervous system effects such as St. John's Wort within the last 2 weeks prior
             to dosing.

          -  Subjects who have a history or presence of narrow-angle glaucoma.

          -  Have a history or presence of significant neuropsychiatric disease (for example,
             maniac-depressive illness, schizophrenia, or depression).

          -  Currently smoke in excess of 10 cigarettes per day, or equivalent in tobacco or
             nicotine substitutes, or are unwilling to stop smoking for the duration specified in
             the protocol

          -  Subjects determined by the investigator or the sponsor to be inadequate for inclusion
             in this study for any other reasons.