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

Depression Clinical Trial

— DWETR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367080
• Other study ID #: DWETR-I-1
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2011
• Last updated: August 6, 2014
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: August 2014
• Source: Dong Wha Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive State
• Enuresis

Intervention

Drug:
• DWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
• DWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital.	Jeonju-si	Jeollabuk-do

Sponsors (2)

Lead Sponsor	Collaborator
Dong Wha Pharmaceutical Co. Ltd.	Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast and AUCinf	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	No
Secondary	Cmax	Maximum Concentration(Cmax) of amitryptyline in plasma	Up to 72 hours	No
Secondary	Tmax	Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma	Up to 72 hours	No
Secondary	t1/2	Terminal half-time(t1/2) of Amitryptyline in Plasma	Up to 72 hours	No