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Bioequivalence of torasemide 5 mg in Korean subjects

Status Approved

First Submitted Date

2013/07/07
Registered Date

2013/07/17
Last Updated Date

2013/07/15

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
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
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Yong-Bok Lee
Title	PhD
Telephone	+82-62-530-2931
Affiliation	Chonnam National University
Address
Contact Person for Public Queries
Name	Yong-Bok Lee
Title	PhD
Telephone	+82-62-530-2931
Affiliation	Chonnam National University
Address
Contact Person for Updating Information
Name	Yong-Bok Lee
Title	PhD
Telephone	+82-62-530-2931
Affiliation	Chonnam National University
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	Chonnam National University
Recruitment Status	Completed
Date of First Enrollment	2006-02-09 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Sam Chun Dang Pharm
Organization Type	Pharmaceutical Company
Project ID	없음

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University
Organization Type	University

7. Study Summary

Study Summary Information
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 Summary Information

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).

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
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	2
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.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~55Year
	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

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Bio-Equivalence
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.

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes
Final Enrollment Number
Number of Publication	1
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

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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