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Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers

NCT03652792 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-29

No results posted yet for this study

Summary

The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Conditions

  • Bioequivalence of Two Azilsartan Formulations

Interventions

DRUG

Azilsartan (Zhaoke)

Azilsartan 20mg tablets from Zhaoke

DRUG

Azilsartan (Takeda)

Azilva 20mg tablets from Takeda

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Pharmaceutical Limited

    collaborator UNKNOWN

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2018-06-25
Completion
2018-07-05

Countries

  • Hong Kong

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 NCT03652792 on ClinicalTrials.gov