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Anastrozole ODF · 1 trial · 2 indications
By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 2 way crossover |
| 2 | EXPERIMENTAL | 2 way crossover |
| 3 | EXPERIMENTAL | 2 way crossover |
| 4 | EXPERIMENTAL | 2 way crossover |
| Name | Type | Description |
|---|---|---|
| Anastrozole ODF | DRUG | Each volunteer will receive a single dose of Anastrozole ODF with water. |
| Arimidex tablet | DRUG | Each volunteer will receive a single dose of Arimidex tablet with water |
Inclusion Criteria: * 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 pro...
Anastrozole ODF is an orally disintegrating film formulation of anastrozole, a small molecule drug developed by AstraZeneca PLC (ticker AZN). It is an investigational product that has been studied in a Phase 1 bioequivalence trial comparing it with the Arimidex tablet in Japanese healthy male subjects.
Anastrozole ODF targets CYP19A1, also known as aromatase. It acts as an inhibitor of this enzyme. By inhibiting CYP19A1, the drug interferes with the aromatase pathway, which is the same molecular target as the established anastrozole tablet formulation.
Anastrozole ODF is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is also the maker of Arimidex, the anastrozole tablet referenced as the comparator in the bioequivalence study of the orally disintegrating film formulation.
Anastrozole ODF is in Phase 1 development. It is an investigational formulation and is not described as approved. The only recorded trial is a completed Phase 1 study, and no active trials are currently listed for this formulation.
Anastrozole ODF has been studied in one clinical trial, NCT01568281, titled a bioequivalence study comparing Arimidex tablet and Anastrozole ODF in Japanese healthy male subjects. The Phase 1 trial was completed, enrolled 58 participants, was randomized and controlled, and was conducted in Japan.