Anastrozole 1 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01182181
First received: August 12, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Anastrozole (Teva Pharmaceuticals USA)
Drug: Anastrozole (Arimidex®)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Anastrozole Cmax.

  • AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Anastrozole AUC0-t.


Enrollment: 22
Study Start Date: August 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Anastrozole Tablets, 1 mg
Drug: Anastrozole (Teva Pharmaceuticals USA)
1 mg Tablets
Active Comparator: Reference Listed Drug
Arimidex® Tablets, 1 mg
Drug: Anastrozole (Arimidex®)
1 mg Tablets
Other Name: Arimidex®

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years or age or older.
  • Body mass index (BMI) between 19 and 30, inclusive.
  • Indicate non-child bearing status by one of the following criteria:

    • Indication of successful hysterectomy.
    • No spontaneous menses for at least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels within postmenopausal range.
    • Indication of successful bilateral oophorectomy.
  • Negative for:

    • HIV.
    • Hepatitis B surface antigen and Hepatitis C antibody.
    • Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, and methadone).
    • Urine cotinine test.
    • Serum pregnancy test.
  • No significant diseases or clinically significant findings in a physical examination.
  • No clinically significant abnormal laboratory values.
  • No clinically significant findings in the 12-lead electrocardiogram (ECG).
  • No clinically significant findings from the vital signs measurement.
  • Be informed of the nature of the study and given written consent prior to receiving any study procedure.
  • Participants in this study will be unable to have children (i.e. post-menopausal, hysterectomy).

Exclusion Criteria:

  • Known history or presence of any clinically significant medical condition.
  • Known or suspected carcinoma.
  • Known history of:

    • Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
    • Alcoholism within the last 12 months.
    • Drug dependence and/or substance abuse.
    • Use of tobacco or nicotine-containing products within the last 6 months.
  • Taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
  • Taken any hormone replacement therapy (HRT) for 4 weeks prior to dosing.
  • On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
  • Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
  • Donated up to 250 mL of blood within the previous 30 days OR donated from 251 to 500 mL of blood in the previous 45 days OR donated more than 500 mL of blood in the previous 56 days.
  • Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
  • Difficulty fasting or consuming the standard meals.
  • Do not tolerate venipuncture.
  • Unable to read or sign the informed consent form.
  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: NCT01182181

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D., Ph.D., FRCP Pharma Medica Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01182181     History of Changes
Other Study ID Numbers: 2005-1042
Study First Received: August 12, 2010
Results First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects
Bioequivalence

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

ClinicalTrials.gov processed this record on July 23, 2014