Healthy Adult SubjectsPhase 1NCT04521192
Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects
A Phase 1 study testing Fluzoparib in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Fluzoparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2019to 5 Sep 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the study, and fully understand the study content, process and possible adverse reactions;
- Able to complete the research in accordance with the requirements of the study protocol;
- Healthy male or female subjects aged 18-50 (including 18 or 50 years old) at the date of signing the informed consent;
- The subject is willing to have no pregnancy plan in the next 6 months and voluntarily take effective contraceptive measures
- Body weight ≥ 45kg, body mass index (BMI) within the range of 18 ~ 28kg /m2 (including 18 and 28);
- Health status: no history of heart, liver, kidney, digestive tract, nervous system, mental disorders, and metabolic disorders;
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- No abnormalities in physical examination or abnormalities without clinical significance;
- Creatinine clearance rate (CLCr) ≥70 mL/min;
- Negative pregnancy test for women of child-bearing age;
Who cannot join
- Pregnant and lactating women, women who have unprotected sex in the 14 days before screening;
- Participated in blood donation within 3 months before screening and donated blood volume ≥400mL or blood loss ≥400mL, or received blood transfusion;
- Allergies, including those with a history of severe drug allergy or drug allergy; a history of allergy to fluzoparib capsules or its excipients.
- Have a history of drug and/or alcohol abuse; alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine; smoking ≥ 5 cigarettes per day) or Those who cannot ban smoking and alcohol during the trial;
- Those who have a history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
- Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc;
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- History of chronic kidney disease, renal impairment, and renal anemia;
- There is a history of dysphagia or any gastrointestinal disease that affects drug absorption;
- Any uncontrolled peptic ulcer, colitis, pancreatitis, etc;
- Those who have undergone any surgery within 6 months before screening;
- A clear medical history of other important organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system (such as uncontrolled diabetes, high blood pressure, etc.), so that the investigator Those who think it is not suitable to participate in this research;
- Hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampin) taken within 6 months before screening;
- Those who have taken any clinical trial drugs within 3 months;
- Any drug that changes liver enzyme activity was taken 28 days before or during the study period;
- Take any prescription or over-the-counter drugs 7 days before taking the study drug;
- Ingested any vitamin products or herbs 7 days before taking the study drug
- Clinical laboratory tests are abnormal and clinically significant, or other clinical findings show the following diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular disease);
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection
- Drinking grapefruit juice and beverages containing xanthine, caffeine, and alcohol 48 hours before taking the study drug, exercising vigorously, or having other factors affecting drug absorption, distribution, metabolism, and excretion;
- The investigator believes that there are other factors that not suitable for participating in this trial;
- Screening for alcohol and drug use was positive or had a history of drug abuse in the past five years or had used drugs in the 3 months prior to the trial;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bridging Study on the Bioequivalence of Fluzoparib Capsules With Different Specifications in Healthy Volunteers
The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd.
The secondary objective of the study is to evaluate the safety of test preparations and reference preparation fluzoparib capsules of different specifications in healthy subjects.
- Conditions
- Healthy Adult Subjects
- Being tested
- Fluzoparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
the first period: test preparation; the second period: reference preparation
FluzoparibDrug
the first period: reference preparation the second period: test preparation
| Study group | Role | What they receive |
|---|---|---|
| TR sequence group | Experimental | Not described Receives: Drug: Fluzoparib |
| RT sequence group | Experimental | Not described Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Fluzoparib
Measured: Up to Day 10
Area Under the Plasma Concentration(AUC) of Fluzoparib
Measured: Up to Day 10
Secondary outcomes (1)
Adverse events
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start6 May 2019
- Primary completion26 Jul 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single dose of oral administration of fluzoparib capsules
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521192
- Sponsor's protocol ID
- FZPL-I-BE-001
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridging Study on the Bioequivalence of Fluzoparib Capsules With Different Specifications in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04521192
- Acronym / sponsor ID
- FZPL-I-BE-001
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 20 Aug 2020 (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 primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd.
The secondary objective of the study is to evaluate the safety of test preparations and reference preparation fluzoparib capsules of different specifications in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single dose of oral administration of fluzoparib capsules
| Arm | Type | Receives |
|---|---|---|
| TR sequence group | Experimental | Drug: Fluzoparib |
| RT sequence group | Experimental | Drug: Fluzoparib |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Sign the informed consent form before the study, and fully understand the study content, process and possible adverse reactions;
- Able to complete the research in accordance with the requirements of the study protocol;
- Healthy male or female subjects aged 18-50 (including 18 or 50 years old) at the date of signing the informed consent;
- The subject is willing to have no pregnancy plan in the next 6 months and voluntarily take effective contraceptive measures
- Body weight ≥ 45kg, body mass index (BMI) within the range of 18 ~ 28kg /m2 (including 18 and 28);
Key exclusion criteria (21 listed)
- Pregnant and lactating women, women who have unprotected sex in the 14 days before screening;
- Participated in blood donation within 3 months before screening and donated blood volume ≥400mL or blood loss ≥400mL, or received blood transfusion;
- Allergies, including those with a history of severe drug allergy or drug allergy; a history of allergy to fluzoparib capsules or its excipients.
- Have a history of drug and/or alcohol abuse; alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine; smoking ≥ 5 cigarettes per day) or Those who cannot ban smoking and alcohol during the trial;
- Those who have a history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
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 |
|---|---|---|
| Fluzoparibthe first period: test preparation; the second period: reference preparation | Drug | TR sequence group |
| Fluzoparibthe first period: reference preparation the second period: test preparation | Drug | RT sequence group |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Fluzoparib
Time frame: Up to Day 10
Area Under the Plasma Concentration(AUC) of Fluzoparib
Time frame: Up to Day 10
1 secondary outcome
Adverse events
Time frame: Up to Day 28
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 20 Aug 2020.
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Healthy Subjects
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 Fluzoparib in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. 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 9 inclusion and 21 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 20 Aug 2020. 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 Fluzoparib (time frame: Up to Day 10). 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 20 Aug 2020.