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

This study has been completed.
Sponsor:
Collaborator:
Chonbuk National University Hospital
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01367080
First received: June 2, 2011
Last updated: August 6, 2014
Last verified: August 2014

June 2, 2011
August 6, 2014
July 2011
August 2011   (final data collection date for primary outcome measure)
AUClast and AUCinf [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
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
  • AUClast of amityptyline in plasma [ Time Frame: UP to 72H ] [ Designated as safety issue: No ]
  • Cmax of Amitryptiline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01367080 on ClinicalTrials.gov Archive Site
  • Cmax [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
    Maximum Concentration(Cmax) of amitryptyline in plasma
  • Tmax [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
    Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
  • t1/2 [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
    Terminal half-time(t1/2) of Amitryptyline in Plasma
  • Tmax of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
  • terminal half-life (t1/2) of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
  • CL/F of amityptyline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Depression
  • Depressive State
  • Enuresis
  • 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: A Group
    1. 1st administration - DWETR10
    2. 2nd administration - DWETR25
    Interventions:
    • Drug: DWETR10
    • Drug: DWETR25
  • Experimental: B Group
    1. 1st administration - DWETR25
    2. 2nd administration - DWETR10
    Interventions:
    • Drug: DWETR10
    • Drug: DWETR25
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Male
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01367080
DWETR-I-1
Yes
Dong Wha Pharmaceutical Co. Ltd.
Dong Wha Pharmaceutical Co. Ltd.
Chonbuk National University Hospital
Principal Investigator: Min-Gul Kim, MD, PhD Chonbuk National University Hospital
Dong Wha Pharmaceutical Co. Ltd.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP