Anastrozole 1 mg Tablets Under Fasting Conditions

NCT01182181 | Completed Phase 1 Results

• 1 other identifier: 2005-1042
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy Subjects; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Investigational Test Product

EXPERIMENTAL

Anastrozole Tablets, 1 mg

Drug: Anastrozole (Teva Pharmaceuticals USA)

Reference Listed Drug

ACTIVE COMPARATOR

Arimidex® Tablets, 1 mg

Drug: Anastrozole (Arimidex®)

Interventions

Anastrozole (Teva Pharmaceuticals USA) DRUG

1 mg Tablets

Investigational Test Product

Anastrozole (Arimidex®) DRUG

1 mg Tablets

Also known as: Arimidex®

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Anastrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, M.D., Ph.D., FRCP

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 15, 2010
• Results First Posted: November 15, 2010

Record last verified: 2010-10

Locations

CA (1)