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

August 6, 2014 updated by: Dong Wha Pharmaceutical Co. Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
        • Chonbuk National University Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Group
  1. 1st administration - DWETR10
  2. 2nd administration - DWETR25
Drug: DWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Other Names:
  • Etravil 10mg
Drug: DWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Other Names:
  • Etravil 25mg
Experimental: B Group
  1. 1st administration - DWETR25
  2. 2nd administration - DWETR10
Drug: DWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Other Names:
  • Etravil 10mg
Drug: DWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Other Names:
  • Etravil 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUClast and AUCinf
Time Frame: 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
Up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Up to 72 hours
Maximum Concentration(Cmax) of amitryptyline in plasma
Up to 72 hours
Tmax
Time Frame: Up to 72 hours
Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Up to 72 hours
t1/2
Time Frame: Up to 72 hours
Terminal half-time(t1/2) of Amitryptyline in Plasma
Up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong Wha Pharmaceutical Co. Ltd.

Collaborators

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Min-Gul Kim, MD, PhD, Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWETR-I-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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