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

Primary Purpose

Depression, Depressive State, Enuresis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWETR10
DWETR25
Sponsored by
Dong Wha Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring depression

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chonbuk National University Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A Group

B Group

Arm Description

1st administration - DWETR10 2nd administration - DWETR25

1st administration - DWETR25 2nd administration - DWETR10

Outcomes

Primary Outcome Measures

AUClast and AUCinf
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

Cmax
Maximum Concentration(Cmax) of amitryptyline in plasma
Tmax
Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
t1/2
Terminal half-time(t1/2) of Amitryptyline in Plasma

Full Information

First Posted
June 2, 2011
Last Updated
August 6, 2014
Sponsor
Dong Wha Pharmaceutical Co. Ltd.
Collaborators
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01367080
Brief Title
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
Acronym
DWETR
Official Title
Clinical Trials 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong Wha Pharmaceutical Co. Ltd.
Collaborators
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive State, Enuresis
Keywords
depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Group
Arm Type
Experimental
Arm Description
1st administration - DWETR10 2nd administration - DWETR25
Arm Title
B Group
Arm Type
Experimental
Arm Description
1st administration - DWETR25 2nd administration - DWETR10
Intervention Type
Drug
Intervention Name(s)
DWETR10
Other Intervention Name(s)
Etravil 10mg
Intervention Description
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Intervention Type
Drug
Intervention Name(s)
DWETR25
Other Intervention Name(s)
Etravil 25mg
Intervention Description
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Primary Outcome Measure Information:
Title
AUClast and AUCinf
Description
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
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum Concentration(Cmax) of amitryptyline in plasma
Time Frame
Up to 72 hours
Title
Tmax
Description
Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Time Frame
Up to 72 hours
Title
t1/2
Description
Terminal half-time(t1/2) of Amitryptyline in Plasma
Time Frame
Up to 72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Gul Kim, MD, PhD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital.
City
Jeonju-si
State/Province
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25308868
Citation
Nam Y, Lim CH, Lee HS, Chung SJ, Chung YH, Shin YK, Kim MG, Sohn UD, Kim HC, Jeong JH. Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers. Clin Ther. 2015 Feb 1;37(2):302-10. doi: 10.1016/j.clinthera.2014.09.010. Epub 2014 Oct 11.
Results Reference
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A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg

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