HealthyPhase 1NCT01183390

Anastrozole 1 mg Tablets Under Fed Conditions

A Phase 1 study testing Anastrozole in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 fed conditions. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Anastrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteCanada
Study dates: Sep 2005to Oct 2005
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years of age or older.
Body mass index between 18 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 stimulation hormone (FSH) levels within the postmenopausal range.
Indication of successful bilateral oophorectomy.

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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).

Who cannot join

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Known history or presence of:
Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
Alcoholism within the past 12 months.
Drug dependence and/or substance abuse.

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fed Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Anastrozole
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnastrozoleDrug
1 mg Tablets
AnastrozoleDrug
Also called Arimidex®
1 mg Tablets

Study groups in NCT01183390
Study group	Role	What they receive
Investigational Test Product	Experimental	Anastrozole 1 mg Tablets Receives: Drug: Anastrozole
Reference Listed Drug	Active comparator	Arimidex® 1 mg Tablets Receives: Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Anastrozole Cmax.
Measured: 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.
Measured: Blood samples collected over a 72 hour period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Oct 2005

First posted17 Aug 2010 (estimated)
Study startSep 2005
Primary completionOct 2005
Study completionOct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01183390
Sponsor's protocol ID: 2005-1043
Status last verified: Oct 2010
First submitted: 13 Aug 2010
Last updated: 16 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fed Conditions
ClinicalTrials.gov ID: NCT01183390
Acronym / sponsor ID: 2005-1043
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 17 Aug 2010 (estimated)
Results: Posted 16 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: AnastrozoleAnastrozole 1 mg Tablets
Reference Listed Drug	Active comparator	Drug: AnastrozoleArimidex® 1 mg Tablets

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years of age or older.
Body mass index between 18 and 30, inclusive.
Indicate non-child bearing status by one of the following criteria:
Negative for:
No significant diseases or clinically significant findings in a physical examination.

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anastrozole1 mg Tablets	Drug	Investigational Test Product
AnastrozoleAlso: Arimidex®1 mg Tablets	Drug	Reference Listed Drug

Primary outcome

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
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.
Bioequivalence based on Anastrozole AUC0-t.

Results and safety

Results posted to the registry on 16 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anastrazole (Test) First	11	11
Arimidex® (Reference) First	11	10

Primary outcome: Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 72 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Anastrazole (Test) n = 21	Arimidex® (Reference) n = 21
Value	14.1 (2.1)	14.2 (1.6)

Anastrazole (Test) vs Arimidex® (Reference): Ratio of the T/R geometric mean x 100: 98.6 (90% CI 95.10 to 102.28)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Anastrazole (Test) n = 21	Arimidex® (Reference) n = 21
Value	498 (93)	501 (86)

Anastrazole (Test) vs Arimidex® (Reference): Ratio of the T/R geometric mean x 100: 99.4 (90% CI 96.99 to 101.80)

Population analysed: All participants that completed the study had their samples analyzed.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anastrazole (Test)	0 of 22 (0%)	3 of 22 (13.6%)	Not reported
Arimidex® (Reference)	0 of 22 (0%)	4 of 22 (18.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xueyu (Eric) Chen, M.D., Ph.D., FRCP principal investigator

Pharma Medica Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anastrozole in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 72 hour period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01183390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.