HealthyPhase 1NCT01155947
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions
A Phase 1 study testing Anastrozole in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 37 to 67 years, 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
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 37 to 67 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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 Fasting Conditions.
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.
Read the 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 fasting conditions.
- Conditions
- Healthy
- Being tested
- Anastrozole
- Keywords
- Bioavailability, Anastrozole, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex® Tablets 1 mg
Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
| Study group | Role | What they receive |
|---|---|---|
| Arimidex | Active comparator | Arimidex® Tablets 1 mg Receives: Drug: Anastrozole |
| Anastrozole | Experimental | Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability based on Cmax and AUC parameters
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mayur Soni, MBBS, Principal investigator, BA Research India Ltd.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155947
- Sponsor's protocol ID
- BA0859093
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2010
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01155947
- Acronym / sponsor ID
- BA0859093
- Conditions
- Healthy
- Keywords
- Bioavailability, Anastrozole, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting 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 fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arimidex | Active comparator | Drug: AnastrozoleArimidex® Tablets 1 mg |
| Anastrozole | Experimental | Drug: AnastrozoleAnastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited |
Who may qualify
- Ages
- 37 to 67 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| AnastrozoleAlso: Arimidex® Tablets 1 mgAnastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited | Drug | Anastrozole, Arimidex |
Primary outcome
Bioavailability based on Cmax and AUC parameters
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
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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.
Mayur Soni, MBBS principal investigator
BA Research India Ltd.,
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anastrozole in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 6 inclusion and 13 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 2 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bioavailability based on Cmax and AUC parameters (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2010.