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Bioequivalence Study of Anastrozole 1 mg Tablet

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01105299
First received: April 15, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].


Condition Intervention
Healthy
Drug: CJ anastrozole 1 mg tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Study of CJ Anastrozole 1mg Tablet and Arimidex® 1 mg Tablet

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed new generation aromatase inhibitor (CJ anastrozole) with existing anastrozole formulation (Arimidex®) in healthy Korean volunteers. This study is designed as single-dose, randomized, double-blind, 2-way crossover trial. Participants were randomized to receive 1 mg of either the CJ anastrozole or Arimidex, followed by a 3-week washout period. And then the alternate formulation was administered. After 10-hour overnight fast drug was administered. For analysis of pharmacokinetic properties, including Cmax and AUClast, blood samples were obtained at 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours after drug administration.

  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 could not 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: NCT01105299

Sponsors and Collaborators
Asan Medical Center
CJ HealthCare Corporation
Investigators
Principal Investigator: Hyeong-Seok Lim, MD Asan Medical Center
  More Information

Additional Information:
No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyeong-Seok Lim/associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01105299     History of Changes
Other Study ID Numbers: CJ_ANS_B01
Study First Received: April 15, 2010
Last Updated: April 15, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
bioequivalence
anastrozole
Healthy subjects
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

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

ClinicalTrials.gov processed this record on November 20, 2014