Bioequivalence Study of Letrozole 2.5 mg Tablets

This study has been completed.

Sponsor:

Information provided by:

Yuhan Corporation

ClinicalTrials.gov Identifier:

NCT01084499

First received: March 9, 2010

Last updated: NA

Last verified: March 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 9, 2010
Last Updated Date	March 9, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioequivalence Study of Letrozole 2.5 mg Tablets
Official Title ^ICMJE	Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
Brief Summary	The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: letrozole 2.5mg tablets
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy male volunteers in the age between 19 to 55 years old Subjects were neither congenital nor chronic diseases. Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form. Exclusion Criteria: Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy) Current clinically significant disorder in history taking or physical examination Acute disease within 14 days preceding the first application of study medication Had an relevant allergic disease Had history of hypersensitivity to drugs or any food Positive for Hepatitis B antigen, Hepatitis C antibody, HIV antibody, or High Quality Syphilis Reagin Test Excessive caffeine, alcohol intake and smoker(caffeine>5 units/day, alcohol>3 units/day(1 unit = pure alcohol 10ml), cigarettes> 20 cigarettes /day) Subjects who excessive alcohol intake or drug which affect drug metabolism enzyme intake within 30 days preceding study History of drug abuse or positive for urinary testing of drugs abuse (amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc.) Has donated whole blood within 60days or apheresis within 14days preceding the first application of study medication Received other investigational drug within 60days preceding the first application of study medication Taken any herbal medicine within 30days, prescription medication within 14 days or over-the-counter drug (except for vitamins, minerals) within 10days preceding the first application of study medication (might affect this study or safety of subjects as judged by the investigator) Subjects couldn't eat ASAN MEDICAL CENTER standard meal or were unsuitable for this study as judged by investigators
Gender	Male
Ages	19 Years to 55 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01084499
Other Study ID Numbers ^ICMJE	YCD143
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Yuhan Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yuhan Corporation
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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