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COMPLETED
NCT07881263
PHASE1

Bioequivalence of a Generic Azilsartan Medoxomil Tablet Compared With the Reference Product (Edarbi®) in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

This study compared a test azilsartan medoxomil potassium tablet (80 mg) with the reference product, Edarbi® (80 mg), in healthy adults. The study included a fasting part and a part in which participants took the study medication after a meal. In each part, participants were randomly assigned to receive both products, one at a time, in a different order. There was a 5-day washout period between doses. Blood samples were collected before and at scheduled times up to 48 hours after each dose to measure azilsartan levels. The researchers assessed whether the two products produced similar drug levels in the blood and monitored safety. The study was designed to evaluate bioequivalence, not to treat hypertension.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-09-09

Completion Date

2024-10-01

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

DRUG

Azilsartan medoxomil potassium tablet (test, 80 mg)

A single oral dose of one 80 mg test tablet per treatment period. Administered under fasting or fed conditions according to the assigned study part. Manufacturer: Hainan Huluwa Pharmaceutical Group Co., Ltd.

DRUG

Azilsartan medoxomil potassium tablet (reference, 80 mg)

A single oral dose of one 80 mg reference tablet per treatment period. Administered under fasting or fed conditions according to the assigned study part. Other name: Edarbi®. Manufacturer: Takeda Ireland Ltd.

Locations (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, China