Therapeutic EquivalencyPhase 1NCT05786339
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects
A Phase 1 study testing Tested Irbesartan Tablet and Reference Irbesartan Tablet in people with Therapeutic Equivalency, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Tested Irbesartan Tablet and Reference Irbesartan Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2018to 15 May 2019
- 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
- Healthy male and female aged over 18years
- Subjects willing to provide written informed consent and to adhere to protocol requirements
- Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
- Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
Who cannot join
- History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder
- Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product
- History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption
- Use of any drugs or herbal medicine within 14 days prior to the first dose
- Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose -
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, 266003
About this study
Official title: Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.
- Conditions
- Therapeutic Equivalency
- Being tested
- Tested Irbesartan Tablet, Reference Irbesartan Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested Irbesartan TabletDrug
T
Reference Irbesartan TabletDrug
R
| Study group | Role | What they receive |
|---|---|---|
| Reference formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC Receives: Drug: Reference Irbesartan Tablet |
| Test formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd. Receives: Drug: Tested Irbesartan Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Evaluation of Peak Plasma Concentration
Measured: 48hours
AUC0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: 484hours
AUC0-∞
Evaluation of Area under the plasma concentration versus time curve
Measured: 48hours
Secondary outcomes (1)
safety
Monitor all the adverse event
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start17 Nov 2018
- Primary completion16 Jan 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Principal investigator, The Affiliated Hosptial of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786339
- Sponsor's protocol ID
- SZHB17-007
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2023
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
- ClinicalTrials.gov ID
- NCT05786339
- Acronym / sponsor ID
- SZHB17-007
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 17 Nov 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 27 Mar 2023 (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 bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference formulation | Experimental | Drug: Reference Irbesartan TabletIrbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC |
| Test formulation | Experimental | Drug: Tested Irbesartan TabletIrbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female aged over 18years
- Subjects willing to provide written informed consent and to adhere to protocol requirements
- Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
- Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
Key exclusion criteria (5 listed)
- History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder
- Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product
- History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption
- Use of any drugs or herbal medicine within 14 days prior to the first dose
- Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last 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 |
|---|---|---|
| Tested Irbesartan TabletT | Drug | Test formulation |
| Reference Irbesartan TabletR | Drug | Reference formulation |
Primary outcome
Cmax
Time frame: 48hours
Evaluation of Peak Plasma Concentration
AUC0-t
Time frame: 484hours
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
AUC0-∞
Time frame: 48hours
Evaluation of Area under the plasma concentration versus time curve
1 secondary outcome
safety
Time frame: 30days
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 27 Mar 2023.
- 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.
Yu Cao principal investigator
The Affiliated Hosptial 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 Tested Irbesartan Tablet and Reference Irbesartan Tablet in people with Therapeutic Equivalency, 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 4 inclusion and 5 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 27 Mar 2023. 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?
Cmax (time frame: 48hours). 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 27 Mar 2023.