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

August 12, 2010
October 15, 2010
August 2005
September 2005   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01182181 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Anastrozole 1 mg Tablets Under Fasting Conditions
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fasting Conditions

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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Anastrozole (Teva Pharmaceuticals USA)
    1 mg Tablets
  • Drug: Anastrozole (Arimidex®)
    1 mg Tablets
    Other Name: Arimidex®
  • Experimental: Investigational Test Product
    Anastrozole Tablets, 1 mg
    Intervention: Drug: Anastrozole (Teva Pharmaceuticals USA)
  • Active Comparator: Reference Listed Drug
    Arimidex® Tablets, 1 mg
    Intervention: Drug: Anastrozole (Arimidex®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2005
September 2005   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01182181
2005-1042
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Xueyu (Eric) Chen, M.D., Ph.D., FRCP Pharma Medica Research Inc.
Teva Pharmaceuticals USA
October 2010

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