Irbesartan Tablets (0.15g/Tablet)Phase 1NCT05297929
A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects
A Phase 1 study testing Irbesartan Tablet in people with Irbesartan Tablets (0.15g/Tablet) and Under Fasted Condition, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition, Under Fed Condition
- What is being tested?
- Irbesartan Tablet
- 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
- 17 Feb 2022to 31 Dec 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male and female subjects aged 18 to 45 years (inclusive);
- Male subjects not less than 50 kg weight, women were not less than 45 kg weight. Scope of body mass index (BMI) of 19.0 ~ 26.0 kg/m2 / BMI = weight (kg)/height (m) 2] (including 19.0 and 26.0);
- Have the ability to communicate with normal researchers/staff and comply with the relevant provisions on the administration of hospital;
- The subject fully understands the purpose, nature, methods and possible adverse reactions of the test, voluntarily acts as a subject, and signs an informed consent before the start of any study program;
- Participants must agree on the non-drug contraception and begin screening and the last time the medicine to prevent pregnancy or within 6 months after with couple of pregnancy.
Who cannot join
- The respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, spirit, system and metabolic abnormalities any clinical history of serious illness, or any other disease which can interfere with the test results or physiological conditions and the researchers judged as abnormal have clinical significance;
- The physical examination, vital signs, abnormal electrocardiogram (ecg) and laboratory examination (unless approved by the researchers determine abnormal no clinical significance).
- Have difficulty swallowing or any affect drug absorption of gastrointestinal diseases history or has a history of digestive surgery, hemorrhoids surgery (appendix except and abdomen ditch hernia repair surgery) or affect the pharmacokinetic factors are known;
- A history of orthostatic hypotension or screening phase orthostatic hypotension;
- In the past year of alcohol abuse, such as drinking more than 14 units of alcohol a week (1 unit of alcohol is equal to 360 ml 150 ml beer or wine or 45 ml 40% distillation wine, such as the spirit Erguotou, etc.) or the whole experiments cannot stop drinkers;
- 3 months prior to screening the average daily amount of more than 5 pieces, or cannot be confirmed and agreed to the first cycle dosing 48 hours before the last time to collect blood before smoking;
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- Human immunodeficiency virus (HIV), hepatitis b surface antigen, treponema pallidum antibody or hepatitis c virus (HCV) antibody is positive;
- Alcohol breath test or drug abuse inspection is positive;
- The first cycle within 3 months before the treatment, attend a group into any clinical trials;
- Within a month before the first cycle to use any other drugs, including prescription drugs or over-the-counter medications (including oral multivitamins, herb medicine, Chinese medicine, medicine stewed food or dietary supplements);
- Subjects were unable to confirm and agree with the first cycle 48 hours before delivery to the front of the last blood ban suits oranges, grapefruits, grapefruit, pomelo, orange, or any alcoholic, xanthine and caffeine foods and beverages, including chocolate, tea, coffee, coke, etc.);
- This product and its analogues, or to any known a complementary makings allergy, or appeared to two or more drugs, such as food allergies or allergic constitution;
- There are galactose intolerance, total lactase deficiency or glucose - galactose malabsorption of rare genetic disease;
- Cannot accept venous blood collection or meals provided by the clinical trial center;
- Drug delivery within one month before the first cycle vaccinated;
- The first cycle for three months before donating blood or blood loss is equal to or more than 400 mL;
- Pregnant or breastfeeding women, or screening in the first two weeks of women with and without protective behavior;
- The researchers determine the subjects are not suitable for participating in this study or for other reasons can not complete the study subjects
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yu Cao
About this study
Official title: Bioequivalence of Irbesartan Tablets (0.15g/Tablet) in a Randomized, Open, Two-cycle, Two-crossover Single Fasting/Postprandial State in Healthy Subjects
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations
- Conditions
- Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition, Under Fed Condition, Bioequivalence
- Being tested
- Irbesartan Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan TabletDrug
Drug: Irbesartan Oral administration on an empty stomach／fed condition
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Reference formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Winthrop Industries Receives: Drug: Irbesartan Tablet |
| Experimental: Test formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Zhejiang Hua Hai Pharmaceutical Co. LTD Receives: Drug: Irbesartan Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Pharmacokinetic parameter AUC0-t estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Measured: up to 1 year
AUC0-∞
Pharmacokinetic parameter AUC0-∞ estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Measured: up to 1 year
Cmax
Pharmacokinetic parameter Cmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Measured: up to 1 year
Tmax
Pharmacokinetic parameter Tmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Measured: up to 1 year
bioequivalence
Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%
Measured: up to 1 year
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE
Number of participants with treatment-related adverse events as assessed by CTCAE
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start17 Feb 2022
- Primary completion9 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irbesartan Tablets (0.15g/Tablet)Studies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, professor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297929
- Sponsor's protocol ID
- BJK-BE-EBST-2021017-ZJHH
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 28 Mar 2022
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Irbesartan Tablets (0.15g/Tablet) in a Randomized, Open, Two-cycle, Two-crossover Single Fasting/Postprandial State in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05297929
- Acronym / sponsor ID
- BJK-BE-EBST-2021017-ZJHH
- Conditions
- Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition, Under Fed Condition, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 9 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Mar 2022 (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.
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Reference formulation | Experimental | Drug: Irbesartan TabletIrbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Winthrop Industries |
| Experimental: Test formulation | Experimental | Drug: Irbesartan TabletIrbesartan tablet (0.15g/tablet) , Manufacturer: Zhejiang Hua Hai Pharmaceutical Co. LTD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects aged 18 to 45 years (inclusive);
- Male subjects not less than 50 kg weight, women were not less than 45 kg weight. Scope of body mass index (BMI) of 19.0 ~ 26.0 kg/m2 / BMI = weight (kg)/height (m) 2] (including 19.0 and 26.0);
- Have the ability to communicate with normal researchers/staff and comply with the relevant provisions on the administration of hospital;
- The subject fully understands the purpose, nature, methods and possible adverse reactions of the test, voluntarily acts as a subject, and signs an informed consent before the start of any study program;
- Participants must agree on the non-drug contraception and begin screening and the last time the medicine to prevent pregnancy or within 6 months after with couple of pregnancy.
Key exclusion criteria (18 listed)
- The respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, spirit, system and metabolic abnormalities any clinical history of serious illness, or any other disease which can interfere with the test results or physiological conditions and the researchers judged as abnormal have clinical significance;
- The physical examination, vital signs, abnormal electrocardiogram (ecg) and laboratory examination (unless approved by the researchers determine abnormal no clinical significance).
- Have difficulty swallowing or any affect drug absorption of gastrointestinal diseases history or has a history of digestive surgery, hemorrhoids surgery (appendix except and abdomen ditch hernia repair surgery) or affect the pharmacokinetic factors are known;
- A history of orthostatic hypotension or screening phase orthostatic hypotension;
- In the past year of alcohol abuse, such as drinking more than 14 units of alcohol a week (1 unit of alcohol is equal to 360 ml 150 ml beer or wine or 45 ml 40% distillation wine, such as the spirit Erguotou, etc.) or the whole experiments cannot stop drinkers;
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 |
|---|---|---|
| Irbesartan TabletDrug: Irbesartan Oral administration on an empty stomach／fed condition | Drug | Experimental: Reference formulation, Experimental: Test formulation |
Primary outcome
AUC0-t
Time frame: up to 1 year
Pharmacokinetic parameter AUC0-t estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
AUC0-∞
Time frame: up to 1 year
Pharmacokinetic parameter AUC0-∞ estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Cmax
Time frame: up to 1 year
Pharmacokinetic parameter Cmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
Tmax
Time frame: up to 1 year
Pharmacokinetic parameter Tmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan
bioequivalence
Time frame: up to 1 year
Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- 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.
Yu Cao, professor principal investigator
The Affiliated Hospital of Qingdao University
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 Irbesartan Tablet in people with Irbesartan Tablets (0.15g/Tablet) and Under Fasted Condition, 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, professor (86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: up to 1 year). The study lists 5 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 28 Mar 2022.