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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
Results First Received: February 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Depression
Depressive State
Enuresis
Interventions: Drug: DWETR10
Drug: DWETR25

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)

Reporting Groups
  Description
A Group 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)
B Group 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)

Participant Flow for 2 periods

Period 1:   1st Administration
    A Group     B Group  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 2:   2nd Administration
    A Group     B Group  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A Group 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)
B Group 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 Total of all reporting groups

Baseline Measures
    A Group     B Group     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  22.2  ± 2.1     21.2  ± 2.1     21.7  ± 1.9  
Gender  
[units: participants]
     
Female     0     0     0  
Male     6     6     12  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     6     6     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AUClast and AUCinf   [ Time Frame: Up to 72 hours ]

2.  Secondary:   Cmax   [ Time Frame: Up to 72 hours ]

3.  Secondary:   Tmax   [ Time Frame: Up to 72 hours ]

4.  Secondary:   t1/2   [ Time Frame: Up to 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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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:  
Name/Title: Cheol-Hee Lim. Clinical Research Manager (CRM)
Organization: Dong Wha Pharm. Co. Ltd.
phone: +82-2-2021-9300 ext 551
e-mail: cheolhee.lim@dong-wha.co.kr


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