SafetyPhase 1NCT01568281
Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
A Phase 1 study testing Anastrozole ODF and Arimidex tablet in people with Safety and Pharmacokinetics, run by AstraZeneca at 1 site in Japan.
Trial summary
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety, Pharmacokinetics
- What is being tested?
- Anastrozole ODF and Arimidex tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2012to Jun 2012
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 18 and 27 kg/m2
Who cannot join
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.
Read the detailed description
A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
- Conditions
- Safety, Pharmacokinetics
- Being tested
- Anastrozole ODF, Arimidex tablet
- Keywords
- Bioequivalence, pharmacokinetics, safety, anastrozole, Arimidex, Japanese, healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastrozole ODFDrug
Each volunteer will receive a single dose of Anastrozole ODF with water.
Arimidex tabletDrug
Each volunteer will receive a single dose of Arimidex tablet with water
Anastrozole ODFDrug
Each volunteer will receive a single dose of Anastrozole ODF without water.
Arimidex tabletDrug
Each volunteer will receive a single dose of Arimidex tablet with water
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 way crossover Receives: Drug: Anastrozole ODF |
| 2 | Experimental | 2 way crossover Receives: Drug: Arimidex tablet |
| 3 | Experimental | 2 way crossover Receives: Drug: Anastrozole ODF |
| 4 | Experimental | 2 way crossover Receives: Drug: Arimidex tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.
Measured: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
Secondary outcomes (2)
Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.
By assessment of AUC, MRT, tmax, kel and t1/2 of anastrozole.
Measured: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.
By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.
Measured: Safety variables are measured prior to treatment and up to 14 to 17 days (follow-up) after the last dose. Subjects will be monitored throughout the study for adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisei Shin, MD, Study director, AstraZeneca R&D JapanKyoko Matsuguma, MD PhD, Principal investigator, Kyushu Clinical Pharmacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568281
- Sponsor's protocol ID
- D539EC00001
- Status last verified
- Jun 2012
- First submitted
- 28 Mar 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01568281
- Acronym / sponsor ID
- D539EC00001
- Conditions
- Safety, Pharmacokinetics
- Keywords
- Bioequivalence, pharmacokinetics, safety, anastrozole, Arimidex, Japanese, healthy subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Apr 2012 (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.
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.
Detailed description
A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Anastrozole ODF2 way crossover |
| 2 | Experimental | Drug: Arimidex tablet2 way crossover |
| 3 | Experimental | Drug: Anastrozole ODF2 way crossover |
| 4 | Experimental | Drug: Arimidex tablet2 way crossover |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 18 and 27 kg/m2
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results
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 |
|---|---|---|
| Anastrozole ODFEach volunteer will receive a single dose of Anastrozole ODF with water. | Drug | 1 |
| Arimidex tabletEach volunteer will receive a single dose of Arimidex tablet with water | Drug | 2 |
| Anastrozole ODFEach volunteer will receive a single dose of Anastrozole ODF without water. | Drug | 3 |
| Arimidex tabletEach volunteer will receive a single dose of Arimidex tablet with water | Drug | 4 |
Primary outcome
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
Time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.
2 secondary outcomes
Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.
Time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.
Time frame: Safety variables are measured prior to treatment and up to 14 to 17 days (follow-up) after the last dose. Subjects will be monitored throughout the study for adverse events
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 25 Jun 2012.
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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.
Eisei Shin, MD study director
AstraZeneca R&D Japan
Kyoko Matsuguma, MD PhD principal investigator
Kyushu Clinical Pharmacology Research Clinic
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 ODF and Arimidex tablet in people with Safety and Pharmacokinetics, run by AstraZeneca at 1 site in Japan.
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 1 inclusion and 3 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 25 Jun 2012. 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 Japan. 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?
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?
Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet. (time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose). 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 25 Jun 2012.