Anastrozole 1 mg Tablets Under Fasting Conditions
This study has been completed.
Sponsor:
Teva Pharmaceuticals USA
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01182181
First received: August 12, 2010
Last updated: October 15, 2010
Last verified: October 2010
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Purpose
Detailed Description:
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
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
Keywords provided by Teva Pharmaceuticals USA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
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 October 17, 2012