A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg

Phase 1

Completed

Conditions: Depression
Enuresis
Depressive State

Interventions: Drug: DWETR10
Drug: DWETR25

Registration Number: NCT01367080

Lead Sponsor: Dong Wha Pharmaceutical Co. Ltd.

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

Detailed Description: Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B Group	DWETR25	1. 1st administration - DWETR25 2. 2nd administration - DWETR10
A Group	DWETR25	1. 1st administration - DWETR10 2. 2nd administration - DWETR25
A Group	DWETR10	1. 1st administration - DWETR10 2. 2nd administration - DWETR25
B Group	DWETR10	1. 1st administration - DWETR25 2. 2nd administration - DWETR10

Primary Outcome Measures

Name	Time	Method
AUClast and AUCinf	Up to 72 hours	Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma

Secondary Outcome Measures

Name	Time	Method
Tmax	Up to 72 hours	Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Cmax	Up to 72 hours	Maximum Concentration(Cmax) of amitryptyline in plasma
t1/2	Up to 72 hours	Terminal half-time(t1/2) of Amitryptyline in Plasma