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
  Purpose

Bioequivalence


Condition Intervention
Healthy
Drug: 1st period - Reference drug
Drug: 1st period - Test drug
Drug: 2nd period - Reference drug
Drug: 2nd period - Test drug

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: Predose(0hr) and post dose 16 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile [ Time Frame: Screening, Pre-dose and Post-dose ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT Group
  1. 1st period: Reference drug
  2. 2nd period: Test drug
Drug: 1st 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: TR Group
  1. 1st period: Test drug
  2. 2nd period: Reference drug
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]

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084499

Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Hyeong-seok Lim, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01084499     History of Changes
Other Study ID Numbers: YCD143
Study First Received: March 9, 2010
Last Updated: July 9, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yuhan Corporation:
Healthy Subjects

Additional relevant MeSH terms:
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014