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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Depression Depressive State Enuresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A Group

1. 1st administration - DWETR10
2. 2nd administration - DWETR25

Group Type EXPERIMENTAL

DWETR10

Intervention Type DRUG

Amitriptyline hydrochloride 10mg(DWETR10) single dose

DWETR25

Intervention Type DRUG

Amitriptyline hydrochloride 25mg(DWETR25) single dose

B Group

1. 1st administration - DWETR25
2. 2nd administration - DWETR10

Group Type EXPERIMENTAL

DWETR10

Intervention Type DRUG

Amitriptyline hydrochloride 10mg(DWETR10) single dose

DWETR25

Intervention Type DRUG

Amitriptyline hydrochloride 25mg(DWETR25) single dose

Interventions

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DWETR10

Amitriptyline hydrochloride 10mg(DWETR10) single dose

Intervention Type DRUG

DWETR25

Amitriptyline hydrochloride 25mg(DWETR25) single dose

Intervention Type DRUG

Other Intervention Names

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Etravil 10mg Etravil 25mg

Eligibility Criteria

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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 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes