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

NCT01367080 | Completed Phase 1 Results DMC

• 1 other identifier: DWETR-I-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Depressive State; Enuresis

Keywords

depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Cmax

  Up to 72 hours

• Tmax

  Up to 72 hours

• t1/2

  Up to 72 hours

Study Arms (2)

A Group

EXPERIMENTAL

1. 1st administration - DWETR10 2. 2nd administration - DWETR25

Drug: DWETR10; Drug: DWETR25

B Group

EXPERIMENTAL

1. 1st administration - DWETR25 2. 2nd administration - DWETR10

Drug: DWETR10; Drug: DWETR25

Interventions

DWETR10 DRUG

Amitriptyline hydrochloride 10mg(DWETR10) single dose

Also known as: Etravil 10mg

A Group; B Group

DWETR25 DRUG

Amitriptyline hydrochloride 25mg(DWETR25) single dose

Also known as: Etravil 25mg

A Group; B Group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead
• Chonbuk National University Hospital: collaborator

Study Sites (1)

Chonbuk National University Hospital.

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Related Publications (1)

• Nam Y, Lim CH, Lee HS, Chung SJ, Chung YH, Shin YK, Kim MG, Sohn UD, Kim HC, Jeong JH. Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers. Clin Ther. 2015 Feb 1;37(2):302-10. doi: 10.1016/j.clinthera.2014.09.010. Epub 2014 Oct 11.

  PMID: 25308868 DERIVED

MeSH Terms

Conditions

Depression; Enuresis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Elimination Disorders; Mental Disorders

Limitations and Caveats

When collecting blood samples, few subjects were drawn blood later than that stated in protocol for about 1 \~ 2 minutes where results may not be effected. One of the subjects came in late for Post-study visit for about 4\~6 days.

Results Point of Contact

• Title: Cheol-Hee Lim. Clinical Research Manager (CRM)
• Organization: Dong Wha Pharm. Co. Ltd.

cheolhee.lim@dong-wha.co.kr

+82-2-2021-9300

Study Officials

• Min-Gul Kim, MD, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

KR (1)