Healthy Volunteers - Male and FemalePhase 1NCT07881263
Bioequivalence of a Generic Azilsartan Medoxomil Tablet Compared With the Reference Product (Edarbi®) in Healthy Chinese Volunteers Under Fasting and Fed Conditions
A Phase 1 study testing Azilsartan medoxomil potassium tablet (test, 80 mg) and Azilsartan medoxomil potassium tablet (reference, 80 mg) in people with Healthy Volunteers - Male and Female, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- Azilsartan medoxomil potassium tablet (test, 80 mg) and Azilsartan medoxomil potassium tablet (reference, 80 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2024to 1 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- Azilsartan medoxomil potassium tablet (test, 80 mg), Azilsartan medoxomil potassium tablet (reference, 80 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan medoxomil potassium tablet (test, 80 mg)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting - Sequence TR | Experimental | Not described Receives: Drug: Azilsartan medoxomil potassium tablet (test, 80 mg); Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fasting - Sequence RT | Experimental | Not described Receives: Drug: Azilsartan medoxomil potassium tablet (test, 80 mg); Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fed - Sequence TR | Experimental | Not described Receives: Drug: Azilsartan medoxomil potassium tablet (test, 80 mg); Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fed - Sequence RT | Experimental | Not described Receives: Drug: Azilsartan medoxomil potassium tablet (test, 80 mg); Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of azilsartan
Measured: 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
Measured: 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
Measured: From predose through 48 hours after each dose; AUC0-inf is calculated by extrapolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start9 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881263
- Sponsor's protocol ID
- CS-2024-11
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of a Generic Azilsartan Medoxomil Tablet Compared With the Reference Product (Edarbi®) in Healthy Chinese Volunteers Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT07881263
- Acronym / sponsor ID
- CS-2024-11
- Conditions
- Healthy Volunteers - Male and Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasting - Sequence TR | Experimental | Drug: Azilsartan medoxomil potassium tablet (test, 80 mg), Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fasting - Sequence RT | Experimental | Drug: Azilsartan medoxomil potassium tablet (test, 80 mg), Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fed - Sequence TR | Experimental | Drug: Azilsartan medoxomil potassium tablet (test, 80 mg), Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
| Fed - Sequence RT | Experimental | Drug: Azilsartan medoxomil potassium tablet (test, 80 mg), Drug: Azilsartan medoxomil potassium tablet (reference, 80 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Fasting - Sequence RT, Fasting - Sequence TR, Fed - Sequence RT, Fed - Sequence TR |
| 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. | Drug | Fasting - Sequence RT, Fasting - Sequence TR, Fed - Sequence RT, Fed - Sequence TR |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azilsartan medoxomil potassium tablet (test, 80 mg) and Azilsartan medoxomil potassium tablet (reference, 80 mg) in people with Healthy Volunteers - Male and Female, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of azilsartan (time frame: From predose through 48 hours after each dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.