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

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ClinicalTrials.gov Identifier: NCT01367080
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
Chonbuk National University Hospital
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Depression Depressive State Enuresis Drug: DWETR10 Drug: DWETR25 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A Group
  1. 1st administration - DWETR10
  2. 2nd administration - DWETR25
 Drug: DWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Other Name: Etravil 10mg

Drug: DWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Other Name: Etravil 25mg
Experimental: B Group
  1. 1st administration - DWETR25
  2. 2nd administration - DWETR10
 Drug: DWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Other Name: Etravil 10mg

Drug: DWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Other Name: Etravil 25mg


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Up to 72 hours ]
    Maximum Concentration(Cmax) of amitryptyline in plasma

  2. Tmax [ Time Frame: Up to 72 hours ]
    Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma

  3. t1/2 [ Time Frame: Up to 72 hours ]
    Terminal half-time(t1/2) of Amitryptyline in Plasma


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367080


Locations
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Korea, Republic of
Chonbuk National University Hospital.
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Chonbuk National University Hospital
Investigators
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Principal Investigator: Min-Gul Kim, MD, PhD Chonbuk National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01367080    
Other Study ID Numbers: DWETR-I-1
First Posted: June 6, 2011    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
depression
Additional relevant MeSH terms:
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Enuresis
Depression
Behavioral Symptoms
Mental Disorders
 Urination Disorders
Urologic Diseases
Elimination Disorders