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Anastrozole ODF

Phase 1

Safety | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

Anastrozole ODF · 1 trial · 2 indications

Phase 1 1
NCT01568281Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male SubjectsSafety
COMPLETED58 Analytics
PHASE1COMPLETED
Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
Safety
NCT0156828158
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Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.
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.
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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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL2 way crossover
2EXPERIMENTAL2 way crossover
3EXPERIMENTAL2 way crossover
4EXPERIMENTAL2 way crossover

Interventions

NameTypeDescription
Anastrozole ODFDRUGEach volunteer will receive a single dose of Anastrozole ODF with water.
Arimidex tabletDRUGEach volunteer will receive a single dose of Arimidex tablet with water
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:Japan
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