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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Each volunteer will receive a single dose of Anastrozole ODF with water.
Each volunteer will receive a single dose of Arimidex tablet with water
Each volunteer will receive a single dose of Anastrozole ODF without water.
Research Site
Fukuoka, Fukuoka, Japan
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.
Time frame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
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.
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.
By assessment of adverse events, clinical laboratory tests, 12-lead ECG, blood pressure, pulse rate and body temperature.
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
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Each volunteer will receive a single dose of Arimidex tablet with water