Bioequivalence of Two Azilsartan FormulationsPhase 1NCT03652792
Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers
A Phase 1 study testing Azilsartan (Zhaoke) and Azilsartan (Takeda) in people with Bioequivalence of Two Azilsartan Formulations, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence of Two Azilsartan Formulations
- What is being tested?
- Azilsartan (Zhaoke) and Azilsartan (Takeda)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jan 2018to 5 Jul 2018
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females between 18 and 40 (inclusive) years of age.
- Weight ≥ 50kg and the body mass index (BMI) within the range 19~24kg/m2 (inclusive);
- Negative urine hCG pregnancy test.
- Non-lactating women and willing to use appropriate contraceptive methods such as an intrauterine device (IUD), diaphragm with spermicides or abstinence or have a sterile sexual partner (e.g., vasectomy) during the whole study period. Men willing to use an appropriate method of contraception (such as condom with spermicide or use by partner of oral, implantable or injectable contraceptives, IUD, diaphragm, with spermicides) or abstinence or will have a sterile sexual partner during the whole study period;
- Subjects understand the nature, significance, possible benefits, inconveniences and potential risks before participating in this trial, understood the trial process, and are voluntary to sign the informed consent form and to participate in this trial.
Who cannot join
- Subjects who have abnormalities with clinical significance in physical examination, laboratory examinations, 12-lead ECGs, chest X-ray;
- Subjects with clinically significant history of orthostatic hypotension, chronic gastrointestinal disease (such as gastric ulcer, gastritis, etc.), renal disease (such as nephritis, pyelonephritis, etc.), or cardiovascular, respiratory, neurological, psychotic, haematological, endocrine or other disorders within the past 6 months before randomization or at the discretion of the investigators;
- Subjects with allergic history to Angiotensin Receptor Blockers or other anti-hypertensive drugs or anti-hypertensive biological agents;
- Sitting systolic blood pressure (SBP) <80mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <50mmHg or >90mmHg at screening;
- With the history of using any drug which will inhibit (chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid and sulphonamide) or induce liver metabolize drug (barbiturate, carbamazepine, aminoglutethimide, grifulvin, ethanol, ammonia methyl propyl, phenytoin, rifampin, glutethimide, dexamethasone, sulfinpyrazone) within 1 month before randomization;
- Vegetarian or abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks prior to screening;
Show all 17Show fewer
- History of alcohol abuse in the last 6 months prior to screening defined as an average weekly intake of greater than 14 unit (one unit is equivalent to 360ml of beer or 45ml of spirits with 40% alcohol content or 150 ml of wine); or subjects with positive alcohol breath test;
- History of smoking >5 cigarettes a day in the last 6 months prior to screening;
- History of drug abuse and taking drugs (such as marijuana, cocaine, opiates, benzodiazepines, amphetamines, barbiturates, tricyclic antidepressant) or subjects with positive urine drug abuse test results;
- Consumption of excessive amount of tea, coffee and/or caffeinated beverage (more than 8 cups/day, 200mL/cup) in the last 1 month prior to screening;
- Subjects who have participated in clinical trial (as subjects) in the last 3 months prior to screening;
- Blood donation of 250 ml or more in the 3 months prior to screening;
- Positive result of hepatitis B antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
- Consumption of grapefruit juice, xanthine diet, chocolate, coffee or tea, carbonated beverages, or any other caffeinated beverages within 48 hours before randomization;
- Strenuous exercise within 48 hours before randomization;
- Administered any drugs (prescription medicine, over-the-counter drug, vitamins, supplements and Chinese herbal medicine) within 2 week before randomization; topical treatment is generally allowed or based on investigators' judgement.
- Subjects who, in the opinion of the investigators, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Phase I Clinical Trial Centre, Chinese University of Hong Kong
Hong Kong, Sha Tin New Territories, 000000
About this study
Official title: Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers
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.
- Being tested
- Azilsartan (Zhaoke), Azilsartan (Takeda)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan (Zhaoke)Drug
Also called Azilsartan
Azilsartan 20mg tablets from Zhaoke
Azilsartan (Takeda)Drug
Also called Azilva
Azilva 20mg tablets from Takeda
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan (Zhaoke) Under Fasting | Experimental | Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fasting condition Receives: Drug: Azilsartan (Zhaoke) |
| Azilsartan (Takeda) Under Fasting | Active comparator | Subjects will take a single Azilva 20mg Tablet under fasting condition Receives: Drug: Azilsartan (Takeda) |
| Azilsartan (Zhaoke) Under Fed | Experimental | Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fed condition Receives: Drug: Azilsartan (Zhaoke) |
| Azilsartan (Takeda) Under Fed | Active comparator | Subjects will take a single Azilva 20mg Tablet under fed condition Receives: Drug: Azilsartan (Takeda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence under Fasting Condition
Measured: 48 hours
Bioequivalence under Fed Condition
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start22 Jan 2018
- Primary completion25 Jun 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence of Two Azilsartan FormulationsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Guangzhou) Pharmaceutical Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652792
- Sponsor's protocol ID
- ZK-HK-AZI-201705
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03652792
- Acronym / sponsor ID
- ZK-HK-AZI-201705
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Guangzhou) Pharmaceutical Limited
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 29 Aug 2018 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Azilsartan (Zhaoke) Under Fasting | Experimental | Drug: Azilsartan (Zhaoke)Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fasting condition |
| Azilsartan (Takeda) Under Fasting | Active comparator | Drug: Azilsartan (Takeda)Subjects will take a single Azilva 20mg Tablet under fasting condition |
| Azilsartan (Zhaoke) Under Fed | Experimental | Drug: Azilsartan (Zhaoke)Subjects will take a single Azilsartan (Zhaoke) 20mg Tablet under fed condition |
| Azilsartan (Takeda) Under Fed | Active comparator | Drug: Azilsartan (Takeda)Subjects will take a single Azilva 20mg Tablet under fed condition |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females between 18 and 40 (inclusive) years of age.
- Weight ≥ 50kg and the body mass index (BMI) within the range 19~24kg/m2 (inclusive);
- Negative urine hCG pregnancy test.
- Non-lactating women and willing to use appropriate contraceptive methods such as an intrauterine device (IUD), diaphragm with spermicides or abstinence or have a sterile sexual partner (e.g., vasectomy) during the whole study period. Men willing to use an appropriate method of contraception (such as condom with spermicide or use by partner of oral, implantable or injectable contraceptives, IUD, diaphragm, with spermicides) or abstinence or will have a sterile sexual partner during the whole study period;
- Subjects understand the nature, significance, possible benefits, inconveniences and potential risks before participating in this trial, understood the trial process, and are voluntary to sign the informed consent form and to participate in this trial.
Key exclusion criteria (17 listed)
- Subjects who have abnormalities with clinical significance in physical examination, laboratory examinations, 12-lead ECGs, chest X-ray;
- Subjects with clinically significant history of orthostatic hypotension, chronic gastrointestinal disease (such as gastric ulcer, gastritis, etc.), renal disease (such as nephritis, pyelonephritis, etc.), or cardiovascular, respiratory, neurological, psychotic, haematological, endocrine or other disorders within the past 6 months before randomization or at the discretion of the investigators;
- Subjects with allergic history to Angiotensin Receptor Blockers or other anti-hypertensive drugs or anti-hypertensive biological agents;
- Sitting systolic blood pressure (SBP) <80mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <50mmHg or >90mmHg at screening;
- With the history of using any drug which will inhibit (chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid and sulphonamide) or induce liver metabolize drug (barbiturate, carbamazepine, aminoglutethimide, grifulvin, ethanol, ammonia methyl propyl, phenytoin, rifampin, glutethimide, dexamethasone, sulfinpyrazone) within 1 month before randomization;
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 (Zhaoke)Also: AzilsartanAzilsartan 20mg tablets from Zhaoke | Drug | Azilsartan (Zhaoke) Under Fasting, Azilsartan (Zhaoke) Under Fed |
| Azilsartan (Takeda)Also: AzilvaAzilva 20mg tablets from Takeda | Drug | Azilsartan (Takeda) Under Fasting, Azilsartan (Takeda) Under Fed |
Primary outcome
Bioequivalence under Fasting Condition
Time frame: 48 hours
Bioequivalence under Fed Condition
Time frame: 48 hours
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 29 Aug 2018.
- Individual participant dataSharing planned: No
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 (Zhaoke) and Azilsartan (Takeda) in people with Bioequivalence of Two Azilsartan Formulations, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
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 5 inclusion and 17 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 29 Aug 2018. 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 Hong Kong. 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?
Bioequivalence under Fasting Condition (time frame: 48 hours). The study lists 2 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 29 Aug 2018.