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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Dong Wha Pharmaceutical Co. Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Chonbuk National University Hospital
Information provided by:
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01367080
First received: June 2, 2011
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Depression
Drug: Etravil 10mg Tablet
Drug: Etravil 25mg Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dong Wha Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • Cmax of Amitryptiline in plasma [ Time Frame: Up to 72H ] [ Designated as safety issue: No ]
  • AUClast of amityptyline in plasma [ Time Frame: UP to 72H ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: June 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etravil 10
Etravil 10mg given by oral administration intervention: drug: experimental Etravil 10mg
Drug: Etravil 10mg Tablet
sigle dose
Experimental: Etravil 25
Etravil 25mg given by orl administration intervention: drug: Experimental Etravil 25mg
Drug: Etravil 25mg Tablet
single dose

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders 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%

    • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367080

Contacts
Contact: Cheol-Hee Lim 82-2-2021-9551 cheolhee.lim@dong-wha.co.kr

Locations
Korea, Republic of
Chonbuk National University Hospital. Not yet recruiting
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
Contact: Min-Gul Kim, MD, PhD    82-63-250-2532    mgkim@ctcf2.com   
Contact: Cheol-Hee Lim, MS    82-2-2021-9551    cheolhee.lim@dong-wha.co.kr   
Principal Investigator: Kim Min-Gul, MD, PhD         
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Chonbuk National University Hospital
Investigators
Principal Investigator: Min-Gul Kim, MD, PhD Chonbuk National University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Cheol-hee Lim, Dong Wha Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01367080     History of Changes
Other Study ID Numbers: DWETR-I-1
Study First Received: June 2, 2011
Last Updated: June 3, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014