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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Anastrozole (Teva Pharmaceuticals USA); Drug: Anastrozole (Arimidex®)

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1R 5A3
      • Pharma Medica Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Arimidex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)	Bioequivalence based on Anastrozole Cmax.	Blood samples collected over a 72 hour period.
AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Bioequivalence based on Anastrozole AUC0-t.	Blood samples collected over a 72 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 13, 2010
• First Posted (Estimate): August 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 15, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: 2005-1042