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Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition

NCT04438733 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-06-30

No results posted yet for this study

Summary

An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted conditions to assess the bioequivalence between two formulations of Anastrozole.

Conditions

  • Healthy Volunteers

Interventions

DRUG

test-anastrozole tablet (Salutas Pharma GmbH)

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

DRUG

reference-anastrozole tablet (Arimidex)

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • yu Cao, doctor · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2020-08-03
Completion
2020-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438733 on ClinicalTrials.gov