Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Anastrozole
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Bioavailability, Anastrozole, Crossover
Eligibility Criteria
Inclusion Criteria:
- 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.
- The subjects should have Estradiol level ≤ 20 pg/ml & serum follicular stimulating hormone (FSH) level ≥ 50 mlU/ml during the screening.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- 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.
- The subjects should be able to communicate effectively with study personnel.
- The subjects should be able to give written informed consent to participate in the study.
Exclusion Criteria:
- The subjects who have a history of allergic responses to Anastrozole or other related drugs.
- The subjects who are using female hormone replacement therapies, thyroid hormone replacement therapies, or antihypertensive therapies.
- 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).
- 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.
- The subjects who have a history or presence of bronchial asthma.
- The subject who have used of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
- 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.
- The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
- The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
- The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
- 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).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arimidex
Anastrozole
Arm Description
Arimidex® Tablets 1 mg
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Outcomes
Primary Outcome Measures
Bioavailability based on Cmax and AUC parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT01155960
First Posted
July 1, 2010
Last Updated
July 1, 2010
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01155960
Brief Title
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioavailability, Anastrozole, Crossover
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arimidex
Arm Type
Active Comparator
Arm Description
Arimidex® Tablets 1 mg
Arm Title
Anastrozole
Arm Type
Experimental
Arm Description
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Arimidex® Tablets 1 mg
Intervention Description
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Primary Outcome Measure Information:
Title
Bioavailability based on Cmax and AUC parameters
Time Frame
3 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
The subjects should have Estradiol level ≤ 20 pg/ml & serum follicular stimulating hormone (FSH) level ≥ 50 mlU/ml during the screening.
The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
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.
The subjects should be able to communicate effectively with study personnel.
The subjects should be able to give written informed consent to participate in the study.
Exclusion Criteria:
The subjects who have a history of allergic responses to Anastrozole or other related drugs.
The subjects who are using female hormone replacement therapies, thyroid hormone replacement therapies, or antihypertensive therapies.
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).
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.
The subjects who have a history or presence of bronchial asthma.
The subject who have used of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
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.
The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronak Modi, MBBS
Organizational Affiliation
BA Research India Ltd.,
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions
We'll reach out to this number within 24 hrs