Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions

July 1, 2010 updated by: Dr. Reddy's Laboratories Limited

An Open Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two Period, Crossover, Single Dose Comparative Oral Bioavailability Study Of Anastrozole Tablets 1 mg (Test) Of Dr. Reddy's Laboratories Ltd., India And ARIMIDEX® Tablets 1 mg (Reference) Of Astrazeneca Pharmaceuticals LP, USA In Post Menopausal Healthy Women Subjects Under Fed Conditions.

The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open label, balanced, randomized, two treatment, two-sequence, two periods, crossover, single dose, comparative oral bioavailability study in healthy, post menopausal women subjects under fed conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

37 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. The subjects should be postmenopausal healthy women who have attained complete menopause naturally or surgically and have not had menstruation for at least one year and are not on hormone replacement therapy.
  2. The subjects should have Estradiol level ≤ 20 pg/ml & serum follicular stimulating hormone (FSH) level ≥ 50 mlU/ml during the screening.
  3. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
  4. The subjects should have a BMI between 18.5 to 26.4 (30-39 years), 18.5 to 27.8 (40-49 years), 18.5 to 28.4 (50-59 years) & 18.5 to 27.5 (60-69 years) weight in kg/ height2 in meter.
  5. The subjects should be able to communicate effectively with study personnel.
  6. The subjects should be able to give written informed consent to participate in the study.

Exclusion Criteria:

  1. The subjects who have a history of allergic responses to Anastrozole or other related drugs.
  2. The subjects who are using female hormone replacement therapies, thyroid hormone replacement therapies, or antihypertensive therapies.
  3. The subjects who have significant diseases or clinically significant abnormal findings during screening, (medical history, physical examination, laboratory evaluations, ECG, X-ray & lower abdominal ultrasonography recordings).
  4. The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
  5. The subjects who have a history or presence of bronchial asthma.
  6. The subject who have used of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
  7. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
  8. The subjects who are smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
  9. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
  10. The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
  11. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
  12. The subjects who have a positive test result for Human Immunodeficiency Virus (HIV) antibody and / or syphilis Rapid Plasma Reagin, Venereal Disease Research Laboratory (RPR/VDRL).
  13. The subject who received an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arimidex
Arimidex® Tablets 1 mg
Drug: Anastrozole
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other Names:
  • Arimidex® Tablets 1 mg
Experimental: Anastrozole
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Drug: Anastrozole
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other Names:
  • Arimidex® Tablets 1 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Bioavailability based on Cmax and AUC parameters
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Reddy's Laboratories Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronak Modi, MBBS, BA Research India Ltd.,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA0859094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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