None listed
Conditions
Interventions
Drug : A single dose of TRYPTANOL Tablets 25 × 1 Tablet(Amitriptyline hydrochloride 25 mg) will be orally administered at 9 AM in the morning period and after 2-week washout period same IP will be adm
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects aged = 25 and = 40 years at the time of consent 2) Subjects with BMI range of =18.0 kg/m2 and < 27.0 kg/m2 and weighing = 55 kg and = 90 kg - BMI = Weight (kg) / Height (m)2 3) Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
Exclusion criteria
Exclusion criteria: 1) Subject with a history or presence of clinically significant active disease of the hepatic, renal, neurological, pulmonary, endocrine, hematological, oncological, genitourinary or psychiatric system. Especially subject with arrythmia, history of myocardial infarction, delirium, cerebral damage, agranulocytosis, glaucoma, prostatic diasease, hyperthyroidism or bipolar disorder 2) Subject with history or presence of diseases or any major surgery that can affect pharmacokinetic or pharmacodynamics evaluation 3) Subject who took known CYP enzyme inducer or inhibitor within 28 days 4) Subject with hypersensitivity to amitriptyline or tricyclic antidepressants or other medication (aspirin or antibiotics) or clinically significant history of hypersensitivity 5) Subject with systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg or heart rate > 100 bpm or < 50 bpm following a 5-minute rest in the sitting position 6) Subject with any of following results: - QT > 500 msec or QTcF > 450 msec in 12-lead ECG - AST or ALT or Total bilirubin exceeding 1.5 x ULN - Positive for depression screening with 2 questions 7) Subject with history of congenital long QT syndrome, family history of sudden death, heart failure, hypokalemia (risk factors of Torsades de pointes) 8) Subject with history of drug abuse or positive result in urine drug screening 9) Within 14 days prior to study medication, use of prescription drug or herbal medication or within 7 days use of any over-the-counter medications (if washout periods are more than 5 half-lives of the drug, can be eligible considering absorption, distribution, metabolism and excretion by the investigator’s judgment) 10) Subject who was administerd of another investigational drug (including investigational drug of bioequivalence trial) within 6 months prior to planned administration of the study medication 11) Subject who donated whole blood within 2 months prior to the first administration or blood component donation within 1 month prior to the first administration 12) Subject who persistently drink (alcohol > 30 g per day) or who cannot quit drinking from 24 hour prior to admission to discharge 13) Subject who smoke excessively (cigarettes > 10 per day) or who cannot quit smoking from 24 hour prior to admission to discharge 14) Subject who consumed grapefruit containing food from 24 hour prior to admission to discharge or who cannot quit consuming during the period 15) Subject who cannot quit drinking caffeine containing beverages (coffee, black tea, green tea, cokes, coffee milk or energy drink) during the hospitalization 16) Subject who do not use medically acceptable contraceptive method during whole study period ? Medically acceptable contraceptive method - intrauterine contraception/device - barrier methods (female condom, diaphragm, sponge, cervical cap) together with spermicidal foam/gel/film/cream/suppository - surgical sterilization (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) 17) Subject who investigator judges ineligible for other reasons 18) Subject with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 19) Subject who consume MAO inhibitors or expected to consume
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F, Vz/F, MRT, metabolic ratio of Amitriptyline and Nortriptyline | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics, Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactKi Young Huh
Seoul National University Hospital
Outcome results
None listed