Multi-national (Korean and Japanese), multi-center clinical trial of amitriptyline

JRCT ID: jRCTs021190009

Registered date:17/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: depression,nocturnal enuresis,peripheral neuralgia (Subjects of this study are healty adult.)
• Date of first enrollment: 01/10/2019
• Target sample size: 6
• Countries of recruitment: Korea,Japan
• Study type: Interventional
• Intervention(s): Healthy volunteers will receive TRYPTANOL Tablets 25 in the morning. They will receive TRYPTANOL Tablets 25 in the afternoon after 2 weeks washout period.

Outcome(s)

• Primary Outcome: Effect of diurnal variation on pharmacokinetics and pharmacodynamics of amitriptyline.

Secondary Outcome

1) Effect of diurnal variation on pharmacokinetics and pharmacodynamics of nortriptyline.
2) Effect of diurnal variation according to CYP2C19 and CYP2D6 genotypes.

Key inclusion & exclusion criteria

• Age minimum: >= 25age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1) Subjects aged >= 25 and =< 40 years at the time of consent, healthy Japanese/Korean volunteer.
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.

Exclude criteria

1) Subject with a history or presence of clinically significant active disease of the hepatic, renal, neurological, pulmonary, endocrine, hematological, oncological, cardiovascular, genitourinary or psychiatric system. Subject with angle closure glaucoma, prostatic disease, hyperthyroidism, manic/depression.
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 prior to study medication
4) Subject with hypersensitivity or clinically significant history of hypersensitivity to amitriptyline or tricyclic antidepressants or other medication (aspirin or antibiotics, etc.)
5) Subject with systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg or heart rate > 100 bpm or < 45 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 exceeding 1.5 x ULN
- positive for depression screening test
7) Subject with history of 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 investigators judgment), or who needs these medication
10) Subject who was administered of another investigational drug (including investigational drug of bioequivalence trial) within 90 days 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, or who got blood transfusion within 1 month prior to the first administration
12) Subject who persistently drink (alcohol > 30 g / day on average) 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) from 24 hour prior to admission to discharge.
16) Subject who do not use medically acceptable contraceptive method during whole study period
17) Subject who investigator judges ineligible for other reasons

Related Information

• Primary Sponsor: Hasunuma Tomoko
• Source(s) of Monetary Support: KoNECT