A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
Condition: Depression; Depressive State; Enuresis
MeSH terms: Enuresis; Depression
Intervention: DWETR10; DWETR25
Intervention description: Amitriptyline hydrochloride 10mg(DWETR10) single dose; Amitriptyline hydrochloride 25mg(DWETR25) single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 19 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: depression

Summary:

      To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride
      film-coated tablet 10mg & 25mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  a healthy adult male within the range of 19 to 50 years old at the time of screening

          -  one with weight of more than 55kg, in the range of IBW 20%

               -  Ideal Body Weight(IBW)(kg)={height(cm)-100}*0.9

          -  one who understood completely about this study after the detailed explanation is
             given, decided to volunteer and gave written informed consent to participate in study
             in compliance with the requirement of the entire protocol.

        Exclusion Criteria:

          -  one with clinically significant disease in liver, kidney, nerve system, respiratory
             system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental
             disease or with medical history

          -  one with glaucoma

          -  one with disorders of micturition include benign prostatic hyperplasia

          -  one with gastrointestinal disease or with gastrointestinal surgical history which can
             affect the absorption of the investigational drug.

          -  one who is allergic or has clinically significant allergic history to the study drug,
             components or tricyclic antidepressants(TCA)

          -  one who shows the following result in vital sign: hypotension(systolic pressure ≤
             100mmHg or diastolic pressure ≤ 65mmHg) or hypertension(systolic pressure ≥ 150mmHg or
             diastolic pressure ≥ 95mmHg)

          -  one who has drug abuse history

          -  one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks
             before study drug administration, or who has taken any over-the-counter (OTC) drugs or
             vitamins (Investigators will determine his eligibility by considering the effect of
             the drug on his safety or pharmacokinetic results in case other inclusion/exclusion
             criteria is satisfied.)

          -  one who has participated in other clinical study within 2 months before study drug
             administration

          -  one who donated whole blood within 2 months or component blood within 1 month or who
             are donated within 1 month before the treatment

          -  one who drank Over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects
             who would not be able to stop drinking alcohol during the hospitalization

          -  one who are heavy smoker more than 10 cigarettes/day within 3 months prior to
             screening or subjects who would not be able to stop smoking during the hospitalization

          -  one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs
             before the hospitalization or who had a beverage containing grapefruits during the
             hospitalization

          -  one with clinically significant observations considered as unsuitable based on medical
             judgment by investigators