Healthy Male VolunteersPhase 1NCT04463173
Food Effect Study of Anaprazole in Healthy Chinese Subjects
A Phase 1 study testing Anaprazole in people with Healthy Male Volunteers, run by Sihuan Pharmaceutical Holdings Group Ltd..
Trial summary
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Anaprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2015to 2 Jul 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily;
- The subject is a Chinese health male adult, aged 18 to 45 years, inclusive;
- The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m^2 and 24.0 kg/m^2, inclusive;
- Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion;
- No medical history of allergy to proton pump inhibitors and no any other drug allergy history;
- The subjects have a good lifestyle and can keep good communication with the investigators and comply with the requirements of clinical trial.
Who cannot join
- Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc), liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or medical history of any other system (cardiovascular, respiratory, psychoneural, hematology, endocrinology and etc) ;
- Has clinical significant abnormal electrolytes (especially hypopotassemia) in screening examination;
- Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings);
- Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal nasal septum；
- With positive result of drug screening test;
- With positive result of nicotine test;
Show all 14Show fewer
- Female participants who are pregnant, breast-feeding or menstral period, or participants has no effective contraception method, or has pregnancy plan in 6 months;
- Has received any drugs: acid-inhibitors, any priscription drug, herb medicine, non-prescription drugs and/or food suppliments (including vitamine) within 2 weeks before randomization;
- Blood donation / blood loss ≥400 mL within 3 months, or participated any other clinical trials within 3 months;
- Known Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;
- Frequent alcoholics (drink more than 2 units of alcohol per day, 1 unit = 330 mL beer or 25 mL liquor or 125 mL wine), or took food or drinks with alcoholics 72 hours before randomization;
- Has taken foods or drinks with xanthine(cafeine) or intensive excercise. Has taken foods or drinks that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 14 days before administration of investigational drugs;
- Smoke more than 5 pieces per week;
- Any conditions in which considered by investigator not be appropriate to participate in this trial.
About this study
Official title: A Single-center, Randomized, Open-labeled, Crossover Phase 1 Study to Evaluate the Pharmakinetics Effect of High Fat Food to Single Dose Administration of Anaprazole in Healthy Chinese Subjects
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
- Conditions
- Healthy Male Volunteers
- Being tested
- Anaprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnaprazoleDrug
single dose, oral administration 30 minutes after breakfast with high fat food.
AnaprazoleDrug
single dose, oral administration before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| High fat food oral administration | Experimental | Anaprazole 40mg, single dose, oral administration 30 minutes after breakfast with high fat food. Receives: Drug: Anaprazole |
| Fasting oral administration | Experimental | Anaprazole 40mg, single dose, oral administration before breakfast. Receives: Drug: Anaprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
AUC is area under the plasma concentration-time curve
Measured: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
Cmax is the peak plasma concentration
Measured: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
Tmax is the time to peak plasma concentration
Measured: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start16 Jun 2015
- Primary completion2 Jul 2015
- Study completion2 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463173
- Sponsor's protocol ID
- 3571-CPK-1002
- Status last verified
- Apr 2015
- First submitted
- 30 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-labeled, Crossover Phase 1 Study to Evaluate the Pharmakinetics Effect of High Fat Food to Single Dose Administration of Anaprazole in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04463173
- Acronym / sponsor ID
- 3571-CPK-1002
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 2 Jul 2015 (actual)
- Study completion
- 2 Jul 2015 (actual)
- First posted
- 9 Jul 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.
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat food oral administration | Experimental | Drug: AnaprazoleAnaprazole 40mg, single dose, oral administration 30 minutes after breakfast with high fat food. |
| Fasting oral administration | Experimental | Drug: AnaprazoleAnaprazole 40mg, single dose, oral administration before breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily;
- The subject is a Chinese health male adult, aged 18 to 45 years, inclusive;
- The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m^2 and 24.0 kg/m^2, inclusive;
- Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion;
- No medical history of allergy to proton pump inhibitors and no any other drug allergy history;
Key exclusion criteria (14 listed)
- Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc), liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or medical history of any other system (cardiovascular, respiratory, psychoneural, hematology, endocrinology and etc) ;
- Has clinical significant abnormal electrolytes (especially hypopotassemia) in screening examination;
- Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings);
- Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal nasal septum；
- With positive result of drug screening test;
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 |
|---|---|---|
| Anaprazolesingle dose, oral administration 30 minutes after breakfast with high fat food. | Drug | High fat food oral administration |
| Anaprazolesingle dose, oral administration before breakfast. | Drug | Fasting oral administration |
Primary outcome
AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
AUC is area under the plasma concentration-time curve
Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
Cmax is the peak plasma concentration
Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose
Tmax is the time to peak plasma concentration
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 9 Jul 2020.
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
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 Anaprazole in people with Healthy Male Volunteers, run by Sihuan Pharmaceutical Holdings Group Ltd..
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 6 inclusion and 14 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 9 Jul 2020. 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?
AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose). 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 9 Jul 2020.