Bioequivalence Study of Letrozole 2.5 mg Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01084499
First received: March 9, 2010
Last updated: July 9, 2014
Last verified: July 2014

March 9, 2010
July 9, 2014
January 2009
April 2009   (final data collection date for primary outcome measure)
Pharmacokinetic profile [ Time Frame: Predose(0hr) and post dose 16 times ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01084499 on ClinicalTrials.gov Archive Site
Safety profile [ Time Frame: Screening, Pre-dose and Post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Letrozole 2.5 mg Tablets
Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets

Bioequivalence

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: 1st period - Reference drug
    FEMARA Tab.[Letrozole 2.5mg] Novartis, Antineoplastics
    Other Name: FEMARA Tab.[Letrozole 2.5mg]
  • Drug: 1st period - Test drug
    FERATRA Tab.[Letrozole 2.5mg] Yuhan Corporation, Antineoplastics
    Other Name: FERATRA Tab.[Letrozole 2.5mg]
  • Drug: 2nd period - Reference drug
    FEMARA Tab.[Letrozole 2.5mg] Novartis, Antineoplastics
    Other Name: FEMARA Tab.[Letrozole 2.5mg]
  • Drug: 2nd period - Test drug
    FERATRA Tab.[Letrozole 2.5mg] Yuhan Corporation, Antineoplastics
    Other Name: FERATRA Tab.[Letrozole 2.5mg]
  • Experimental: RT Group
    1. 1st period: Reference drug
    2. 2nd period: Test drug
    Interventions:
    • Drug: 1st period - Reference drug
    • Drug: 2nd period - Test drug
  • Experimental: TR Group
    1. 1st period: Test drug
    2. 2nd period: Reference drug
    Interventions:
    • Drug: 1st period - Test drug
    • Drug: 2nd period - Reference drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Male
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01084499
YCD143
No
Yuhan Corporation
Yuhan Corporation
Not Provided
Principal Investigator: Hyeong-seok Lim, MD, PhD Asan Medical Center
Yuhan Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP