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Trial record 45 of 135 for:    AMITRIPTYLINE

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

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ClinicalTrials.gov Identifier: NCT01367080
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
Chonbuk National University Hospital
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Depression
Depressive State
Enuresis
Interventions Drug: DWETR10
Drug: DWETR25
Enrollment 12
Recruitment Details Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011
Pre-assignment Details 15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)
Arm/Group Title A Group B Group
Hide Arm/Group Description Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day) Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
Period Title: 1st Administration
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: 2nd Administration
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title A Group B Group Total
Hide Arm/Group Description Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day) Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day) Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
22.2  (2.1) 21.2  (2.1) 21.7  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title AUClast and AUCinf
Hide Description 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
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etravil 10mg Group Etravil 25mg Group
Hide Arm/Group Description:
Amitryptiline Hydrochloride 10mg administration Group
Amitryptiline hydrochloride 25mg administration Group
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
AUClast 91.35  (25.88) 260.68  (111.57)
AUCinf 109.74  (37.80) 296.87  (124.99)
2.Secondary Outcome
Title Cmax
Hide Description Maximum Concentration(Cmax) of amitryptyline in plasma
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etravil 10mg Group Etravil 25mg Group
Hide Arm/Group Description:
Amitryptiline Hydrochloride 10mg Administration Group
Amitryptiline Hydrochloride 25mg Administration Group
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.96  (1.40) 17.69  (5.27)
3.Secondary Outcome
Title Tmax
Hide Description Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etravil 10mg Group Etravil 25mg Group
Hide Arm/Group Description:
Amitryptiline Hydrochloride 10mg Administration Group
Amitryptiline Hydrochloride 25mg Administration Group
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: hour
3.50  (0.90) 3.13  (0.61)
4.Secondary Outcome
Title t1/2
Hide Description Terminal half-time(t1/2) of Amitryptyline in Plasma
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etravil 10mg Group Etravil 25mg Group
Hide Arm/Group Description:
Amitryptiline Hydrochloride 10mg Administration Group
Amitryptiline Hydrochloride 25mg Administration Group
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: hour
26.47  (5.64) 24.79  (3.22)
Time Frame About a month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etravil 10mg Group Etravil 25mg Group
Hide Arm/Group Description Amitryptyline hydrochloride 10mg administration Group Amitryptyline hydrochloride 25mg administration Group
All-Cause Mortality
Etravil 10mg Group Etravil 25mg Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etravil 10mg Group Etravil 25mg Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etravil 10mg Group Etravil 25mg Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      2/12 (16.67%)    
General disorders     
Asthenia  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Nervous system disorders     
Dizziness  1  2/12 (16.67%)  2 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1

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.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cheol-Hee Lim. Clinical Research Manager (CRM)
Organization: Dong Wha Pharm. Co. Ltd.
Phone: +82-2-2021-9300 ext 551
EMail: cheolhee.lim@dong-wha.co.kr
Layout table for additonal information
Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01367080     History of Changes
Other Study ID Numbers: DWETR-I-1
First Submitted: June 2, 2011
First Posted: June 6, 2011
Results First Submitted: February 20, 2013
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014