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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2013/07/07
    • Registered Date : 2013/07/17
    • Last Updated Date : 2013/07/15
Background Information
1.Background  
CRIS Registration Number KCT0000795 
Unique Protocol ID BABE-20050507-01삼천 
Public/Brief Title Bioequivalence of torasemide 5 mg in Korean subjects 
Scientific Title Bioequivalence of torasemide 5 mg in Korean subjects  
Acronym BE of Sam Chun Dang Torad tablet 
MFDS Regulated Study Yes
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number CNUP-IBABE-2005-05-14 
Approval Date 2005-05-14 
Institutional Review Board  
- Name Institutional Review Board of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Yong-Bok Lee 
- Title PhD 
- Telephone  
- Affiliation Chonnam National University 
- Address  
Contact Person for Public Queries
- Name Yong-Bok Lee 
- Title PhD 
- Telephone  
- Affiliation Chonnam National University 
- Address  
Contact Person for Updating Information
- Name Yong-Bok Lee 
- Title PhD 
- Telephone  
- Affiliation Chonnam National University 
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2006-02-09 , Actual
Target Number of Participant 28
Primary Completion Date 2006-02-16 , Actual
Study Completion Date 2006-03-30 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Chonnam National University 
- Recruitment Status Completed  
- Date of First Enrollment 2006-02-09 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Sam Chun Dang Pharm  
- Organization Type Pharmaceutical Company  
- Project ID 없음 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Chonnam National University 
- Organization Type University  
Study Summary
7. Study Summary  
Lay Summary The purpose of this study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (5 mg, Roche Korea Co., Ltd., Korea, reference drug) and Sam Chun Dang Torad tablet (5 mg, Sam Chun Dang Pharm. Co,, Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA).  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Others (Bioequivalence Test)
Phase Not applicable 
Intervention Model Cross-over  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description Test drug: Sam Chun Dang Pharm. Co., Ltd., "Torad tablet 5 mg (torasemide 5 mg)", 2 tablets, once per oral
Reference drug: Roche Korea Co., Ltd., "Torem tablet 5 mg (torasemide 5 mg)", 2 tablets, once per oral
 
Number of Arms
Arm 1 Arm Label Group A 
Target Number of Participant 14 
Arm Type Others 
Arm Description Period 1: Sam Chun Dang Pharm. Co., Ltd., "Torad tablet 5 mg (torasemide 5 mg)" 2 tablets, once per oral with water 240 ml. Period 2: Roche Korea Co., Ltd., "Torem tablet 5 mg (torasemide 5 mg)", 2 tablets, once per oral with water 240 ml. 
Arm 2 Arm Label Group B 
Target Number of Participant 14 
Arm Type Others 
Arm Description Period 1: Roche Korea Co., Ltd., "Torem tablet 5 mg (torasemide 5 mg)", 2 tablets, once per oral with water 240 ml. Period 2: Sam Chun Dang Pharm. Co., Ltd., "Torad tablet 5 mg (torasemide 5 mg)" 2 tablets, once per oral with water 240 ml. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Not Applicable
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 55 Year
Description 1. Subjects between the ages of 19 and 55 years
2. No History of congenital or chronic disease
3. No clinically relevant abnormalities identified by laboratory test, including hematology, blood chemistry, and urinalysis
4. Female subject known to be negative for pregnant test  
Exclusion Criteria 1. Use of any drugs (Barbitals, alcohol) known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing
2. Received any drugs within 10 days before the study
3. Inappropriate subject for entry into this study in the judgement of the investigator  
Healthy Volunteers Yes
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Bio-Equivalence 
Primary Outcome(s) 1 
- Outcome AUC(area under the serum concentration-time curve) 
- Timepoint The area under the serum concentration-time curve from time zero to 12 hr of each subject 
Primary Outcome(s) 2 
- Outcome Cmax(maximum serum drug concentration) 
- Timepoint The maximum serum drug concentration from time zero to 12 hr of each subject  
Secondary Outcome(s) 1 
- Outcome The 90% confidence intervals using logarithmically transformed AUC and Cmax were within the acceptance range of log0.80 to log1.25. 
- Timepoint After the drug concentrations were determined. 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd Yes
Final Enrollment Number
Number of Publication
Publications 1 Hyun-Ah Kang, Hwa Yoon, Yong-Bok Lee. Bioequivalence of Torad tablet 5 mg to Torem tablet 5 mg (torasemide 5 mg). Journal of Pharmaceutical Investigation. Non SCI. 2013-04-01 ,   VOL : 43   page : 153 ~ 159
Results Upload  
Date of Posting Results 2013-07-17
Protocol URL or File Upload  
Brief Summary  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration