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
  Purpose

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


Condition Intervention Phase
Depression
Depressive State
Enuresis
Drug: DWETR10
Drug: DWETR25
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:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  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%

    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Principal Investigator: Min-Gul Kim, MD, PhD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: 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
Results First Received: February 20, 2013
Last Updated: August 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
depression

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 October 16, 2014