HypertensionPhase 1NCT02786082
Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers
A Phase 1 study testing 20mg Azilsartan Tablets and 40mg Azilsartan Tablets in people with Hypertension, run by Lee's Pharmaceutical Limited.
Trial summary
The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and providing evidence for clinical study and clinical application of this product. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- 20mg Azilsartan Tablets and 40mg Azilsartan Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 30 Nov 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects in all groups will be adult females or adult males between 18 and 45 (inclusive) years of age, the year age difference between each subject cannot be more than 10.
- Body mass index (BMI) within the range 19~25kg/m2 (inclusive). BMI=weight (kg)/height(m)2。
- Subjects are eligible to participate if the results of physical examination （height, weight, respiration, pulse, blood pressure, thorax, abdomen, etc） and laboratory examination (blood routine examination, urine routine test, blood chemistry test, infectious disease screening, etc) are normal, the tests above will be conducted to all the subjects before the trial initiating. The results of ECG and chest X-ray are normal or slightly abnormal without clinical significance.
- Subjects should not have history of cardiovascular disease, liver disease, renal disease, digestive disease, psychiatric disease, neuropathy disease, etc.
- Subjects who do not have allergic history of Angiotensin Receptor Blockers, the other drugs and biological agents.
- Subjects who are not addicted to smoking and alcohol and without the other bad habits.
- Subjects have not participated in other clinical trial and donated blood within 3 months prior to this trial,
- Subjects have well known the nature, significance, possible benefits, inconveniences and potential risks before participating in this trial and understood the trial process. Subjects are voluntary to participate in this trial.
Who cannot join
- Subjects who have abnormalities with clinical significance in physical examination, laboratory examination, 12-lead ECGs, chest X-ray.
- Subjects with history of orthostatic hypotension, gastrointestinal disease (such as gastric ulcer, gastritis, etc), renal disease (such as nephritis, nephropyelitis, etc), or cardiovascular, respiratory, neurological, psychotic, haematological, endocrine or the other disorders.
- Subjects with allergic constitution with history of sensitivity to Angiotensin Receptor Blockers or a history of the other drugs and biological agent.
- Systolic blood pressure (SBP) <90mmHg or >140mmHg, and/or diastolic blood pressure (DBP) <50mmHg or >90mmHg. Subjects with orthostatic hypotension (at screening, symptomatic or asymptomatic orthostatic hypotension is defined as: subject lying down comfortably for 5 minutes, the blood pressure which is recorded at 5 min considered to be the baseline. The time point of subject stands is considered to be the onset time. Orthostatic hypotension is diagnosed by a rise in systolic blood pressure of 20mmHg or more, or a decrease in diastolic blood pressure of 20mmHg or more, when standing with arms relaxing).
- Vegetarian.
- Subjects who plan to bear children in 6 months.
Show all 12Show 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). History of smoking >5 cigarettes a day in the last 6 months prior to screening.
- History of administrating any drugs that will effect this trial. Subjects who have participated in donation of blood or any drug clinical trial(as subjects) in the last 3 months, or are taking any other drugs.
- Hepatitis B patients, or Hepatitis C patients, or hepatitis C carrier, or subjects with immunodeficiency, or positive HIV antibody results, or positive syphilis antibody results.
- 72 hours prior to randomization, subjects with history of special diet (includes grapefruit, xanthine diet, chocolate, caffeinated coffee or tea, or any other caffeinated beverages) or strenuous exercise, or with the other factors that will effect the absorption, distribution, metabolism and excretion.
- Subjects who took prescription drugs 2 weeks before study.
- Subjects who, in the opinion of the investigators, should not participate in the study.
About this study
Official title: Single Center, Randomized, Open Labeled Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers
The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and providing evidence for clinical study and clinical application of this product.
Read the detailed description
This is a Single center, randomized, open labeled study. The study is conducted to evaluate the pharmacokinetics Studies of Azilsartan with single-dose oral administration, multiple-dose oral administration and effects of diet.
- Pharmacokinetics Studies of Azilsartan with Single-dose oral administration: 24 healthy subjects will be randomly divided into 2 groups evenly, Group I and Group II, with 12 subjects in each group, half are male and half are female. Group I will take Azilsartan tablet 20mg orally on fasting, while Group II will take Azilsartan tablet 40mg orally on fasting. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
2）Pharmacokinetic Studies of Azilsartan Tablets with Multiple-dose oral administration Subjects in Group I will take 20mg Azilsartan orally once daily for 7 day (day 3~day 9) after completing the last time blood sample collection (in day 2, 48h) of the first time administration (day 1). 5mL blood sample will be collected from vein on day 7, day 8 and day 9 for measuring minimum observed concentration before drug administration. On day 9, after administration, blood sampling time is the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
3）The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in single-dose administration study), after 7-day washout period after the first administration (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8, and the blood sampling time point after administration is the same as in single-dose administration study. The process, storage condition of the blood samples are the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
- Conditions
- Hypertension
- Being tested
- 20mg Azilsartan Tablets, 40mg Azilsartan Tablets
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20mg Azilsartan TabletsDrug
Strength: 20mg, oral administration 1 tablet/ day
40mg Azilsartan TabletsDrug
Strength: 40mg, oral administration 1 tablet/ day
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | For Pharmacokinetics Studies of Azilsartan with Single-dose oral administration, 12 subjects in group I, half are male and half are female, will take Azilsartan tablet 20mg orally on fasting.
For Pharmacokinetics Studies of Azilsartan with Multiple-dose oral administration, 12 subjects in group I will take 20mg Azilsartan orally once daily for 7 day (day 3~day 9) after completing the last time blood sample collection (in day 2, 48h) of the first time administration (day 1) Receives: Drug: 20mg Azilsartan Tablets |
| Group II | Experimental | For Pharmacokinetics Studies of Azilsartan with Single-dose oral administration, 12 subjects in group II, half are male and half are female, will take Azilsartan tablet 40mg orally on fasting.
For The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in single-dose administration study), after 7-day washout period after the first administration (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8 Receives: Drug: 40mg Azilsartan Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
To observe area under curve characteristics of Azilsartan in 20mg and 40mg single dose and 20mg multiple dose groups
Measured: Pre-dose, 15 minutes, 30 minutes, 1 hour, 1.5 hour , 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours after administration
Area Under Curve (AUC)
To observe area under curve characteristics of Azilsartan in fasting and high fat diet group
Measured: Pre-dose, 15 minutes, 30 minutes, 1 hour, 1.5 hour , 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start1 Nov 2016
- Primary completion31 Aug 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786082
- Sponsor's protocol ID
- Zhaoke-201603-Azil
- Status last verified
- Sep 2018
- First submitted
- 24 May 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized, Open Labeled Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02786082
- Acronym / sponsor ID
- Zhaoke-201603-Azil
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 30 May 2016 (estimated)
- 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 main objective is to study the pharmacokinetics of Azilsartan Tablets in human and providing evidence for clinical study and clinical application of this product.
Detailed description
This is a Single center, randomized, open labeled study. The study is conducted to evaluate the pharmacokinetics Studies of Azilsartan with single-dose oral administration, multiple-dose oral administration and effects of diet.
- Pharmacokinetics Studies of Azilsartan with Single-dose oral administration: 24 healthy subjects will be randomly divided into 2 groups evenly, Group I and Group II, with 12 subjects in each group, half are male and half are female. Group I will take Azilsartan tablet 20mg orally on fasting, while Group II will take Azilsartan tablet 40mg orally on fasting. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
2）Pharmacokinetic Studies of Azilsartan Tablets with Multiple-dose oral administration Subjects in Group I will take 20mg Azilsartan orally once daily for 7 day (day 3~day 9) after completing the last time blood sample collection (in day 2, 48h) of the first time administration (day 1). 5mL blood sample will be collected from vein on day 7, day 8 and day 9 for measuring minimum observed concentration before drug administration. On day 9, after administration, blood sampling time is the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
3）The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in single-dose administration study), after 7-day washout period after the first administration (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8, and the blood sampling time point after administration is the same as in single-dose administration study. The process, storage condition of the blood samples are the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: 20mg Azilsartan TabletsFor Pharmacokinetics Studies of Azilsartan with Single-dose oral administration, 12 subjects in group I, half are male and half are female, will take Azilsartan tablet 20mg orally on fasting. For Pharmacokinetics Studies of Azilsartan with Multiple-dose oral administration, 12 subjects in group I will take 20mg Azilsartan orally once daily for 7 day (day 3~day 9) after completing the last time blood sample collection (in day 2, 48h) of the first time administration (day 1) |
| Group II | Experimental | Drug: 40mg Azilsartan TabletsFor Pharmacokinetics Studies of Azilsartan with Single-dose oral administration, 12 subjects in group II, half are male and half are female, will take Azilsartan tablet 40mg orally on fasting. For The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in single-dose administration study), after 7-day washout period after the first administration (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects in all groups will be adult females or adult males between 18 and 45 (inclusive) years of age, the year age difference between each subject cannot be more than 10.
- Body mass index (BMI) within the range 19~25kg/m2 (inclusive). BMI=weight (kg)/height(m)2。
- Subjects are eligible to participate if the results of physical examination （height, weight, respiration, pulse, blood pressure, thorax, abdomen, etc） and laboratory examination (blood routine examination, urine routine test, blood chemistry test, infectious disease screening, etc) are normal, the tests above will be conducted to all the subjects before the trial initiating. The results of ECG and chest X-ray are normal or slightly abnormal without clinical significance.
- Subjects should not have history of cardiovascular disease, liver disease, renal disease, digestive disease, psychiatric disease, neuropathy disease, etc.
- Subjects who do not have allergic history of Angiotensin Receptor Blockers, the other drugs and biological agents.
Key exclusion criteria (12 listed)
- Subjects who have abnormalities with clinical significance in physical examination, laboratory examination, 12-lead ECGs, chest X-ray.
- Subjects with history of orthostatic hypotension, gastrointestinal disease (such as gastric ulcer, gastritis, etc), renal disease (such as nephritis, nephropyelitis, etc), or cardiovascular, respiratory, neurological, psychotic, haematological, endocrine or the other disorders.
- Subjects with allergic constitution with history of sensitivity to Angiotensin Receptor Blockers or a history of the other drugs and biological agent.
- Systolic blood pressure (SBP) <90mmHg or >140mmHg, and/or diastolic blood pressure (DBP) <50mmHg or >90mmHg. Subjects with orthostatic hypotension (at screening, symptomatic or asymptomatic orthostatic hypotension is defined as: subject lying down comfortably for 5 minutes, the blood pressure which is recorded at 5 min considered to be the baseline. The time point of subject stands is considered to be the onset time. Orthostatic hypotension is diagnosed by a rise in systolic blood pressure of 20mmHg or more, or a decrease in diastolic blood pressure of 20mmHg or more, when standing with arms relaxing).
- Vegetarian.
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 |
|---|---|---|
| 20mg Azilsartan TabletsStrength: 20mg, oral administration 1 tablet/ day | Drug | Group I |
| 40mg Azilsartan TabletsStrength: 40mg, oral administration 1 tablet/ day | Drug | Group II |
Primary outcome
Area Under Curve (AUC)
Time frame: Pre-dose, 15 minutes, 30 minutes, 1 hour, 1.5 hour , 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours after administration
To observe area under curve characteristics of Azilsartan in 20mg and 40mg single dose and 20mg multiple dose groups
Area Under Curve (AUC)
Time frame: Pre-dose, 15 minutes, 30 minutes, 1 hour, 1.5 hour , 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours after administration
To observe area under curve characteristics of Azilsartan in fasting and high fat diet group
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 5 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 20mg Azilsartan Tablets and 40mg Azilsartan Tablets in people with Hypertension, run by Lee's Pharmaceutical Limited.
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 8 inclusion and 12 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Area Under Curve (AUC) (time frame: Pre-dose, 15 minutes, 30 minutes, 1 hour, 1.5 hour , 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours after administration). 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 5 Sep 2018.