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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
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
Conditions
Interventions
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.
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