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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.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 58 |
| Start date | 2012-04 |
| Completion | 2012-06 |
Conditions
- Safety
- Pharmacokinetics
Interventions
- Anastrozole ODF
- Arimidex tablet
- Anastrozole ODF
- Arimidex tablet
Primary outcomes
- Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet. — 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.
Countries
Japan