A Phase 1 interventional study of Azilsartan medoxomil potassium tablet (test, 80 mg) and Azilsartan medoxomil potassium tablet (reference, 80 mg) in Healthy Volunteers - Male and Female, sponsored by The Affiliated Hospital of Qingdao University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by The Affiliated Hospital of Qingdao University · Phase 1, Interventional, and Other
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.
The Affiliated Hospital of Qingdao University is the lead sponsor of 146 studies on the registry; 55 are open to participants now.
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1.Provide written informed consent before any study procedures. 2.Be 18 years of age or older; male or female. 3.Weigh at least 50 kg if male or 45 kg if female, with a body mass index (BMI) of 19.0 to 26.0 kg/m², inclusive.
4.Have vital signs, physical examination, 12-lead ECG, and clinical laboratory test results (including hematology, urinalysis, blood chemistry, coagulation, infectious disease screening, and pregnancy testing for females) that are normal or considered not clinically significant by the investigator.
5.Have no plans to become pregnant, father a child, or donate sperm or eggs through 90 days after the last dose, and agree to use non-drug contraception during the study.
Exclusion Criteria:
1.History of allergy to two or more drugs, foods, or environmental substances; allergy to azilsartan medoxomil potassium, similar drugs, or any tablet excipient.
2.Current or previous severe or chronic disease considered clinically significant by the investigator, including musculoskeletal, gastrointestinal, endocrine, respiratory, urinary, reproductive, cardiovascular, or neurological disease.
3.Previous surgery considered likely to affect drug absorption, distribution, metabolism, or excretion, including liver, kidney, or gastrointestinal resection, or planned surgery during the study.
4.Vaccination within 4 weeks before the first dose, or planned vaccination during the study.
5.Use of any prescription or nonprescription medication, traditional Chinese medicine, or health supplement within 14 days before the first dose.
6.Participation in another clinical trial involving a drug, vaccine, or medical device within 3 months before the first dose.
7.Blood donation or substantial blood loss (≥400 mL) within 3 months before the first dose, or planned blood donation through 1 month after the last dose.
8.Regular alcohol consumption exceeding 14 units per week during the 6 months before the study; unwillingness to abstain from alcohol during the study; or a positive alcohol test.
9.Average smoking of ≥5 cigarettes per day during the 3 months before screening, or inability to abstain from nicotine-containing products during the study.
10.Drug abuse within 12 months before the first dose, or a positive urine drug screen.
11.Inability to tolerate venipuncture or a history of fainting related to needles or blood.
12.Lactose intolerance. 13.Special dietary requirements that prevent compliance with the study diet. 14.Consumption of foods such as grapefruit, strenuous exercise, or other factors that may affect drug absorption, distribution, metabolism, or excretion within 7 days before the first dose.
15.Consumption of more than 8 cups of tea, coffee, or other caffeinated beverages per day during the 3 months before screening, or consumption of caffeine-containing or xanthine-rich foods or drinks within 48 hours before the first dose.
16.Use of oral contraceptives within 30 days before the first dose, or use of long-acting estrogen or progesterone injections or implants within 6 months before the first dose (females).
17.Pregnancy or breastfeeding, or unprotected sexual intercourse within 14 days before screening (females).
18.Inability to participate for personal reasons. 19.Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Drug: Azilsartan medoxomil potassium tablet (test, 80 mg) · Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg)
Drug: Azilsartan medoxomil potassium tablet (test, 80 mg) · Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg)
Drug: Azilsartan medoxomil potassium tablet (test, 80 mg) · Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg)
Drug: Azilsartan medoxomil potassium tablet (test, 80 mg) · Drug: Azilsartan medoxomil potassium tablet (reference, 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.
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.
Maximum observed plasma concentration (Cmax) of azilsartan
Time frame: From predose through 48 hours after each dose
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of azilsartan
Time frame: From predose through 48 hours after each dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of azilsartan
Time frame: From predose through 48 hours after each dose; AUC0-inf is calculated by extrapolation
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University →