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This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2 way crossover |
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| 2 | Experimental | 2 way crossover |
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| 3 | Experimental | 2 way crossover |
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| 4 | Experimental | 2 way crossover |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole ODF | Drug | Each volunteer will receive a single dose of Anastrozole ODF with water. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eisei Shin, MD | AstraZeneca R&D Japan | Study Director |
| Kyoko Matsuguma, MD PhD | Kyushu Clinical Pharmacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Arimidex tablet |
| Drug |
Each volunteer will receive a single dose of Arimidex tablet with water |
|
| Anastrozole ODF | Drug | Each volunteer will receive a single dose of Anastrozole ODF without water. |
|
| Arimidex tablet | Drug | Each volunteer will receive a single dose of Arimidex tablet with water |
|
By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature. |
| 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 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |