HypertensionPhase 1NCT03249753
The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
A Phase 1 study testing SPH3127 200mg Panel A and SPH3127 200mg Panel B in people with Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- SPH3127 200mg Panel A and SPH3127 200mg Panel B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2017to 30 Sep 2018
- 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
- The body mass index is 19 ~ 26kg/m2 (including the critical value), which allows the minimum weight of male to be 50kg (including the critical value) and 45kg (the critical value) for women.
- Before the study, participants have kown about the significance, potential benefits, inconveniences and potential risks of the study and can follow the research's procedure and already sign the informed consent
Who cannot join
- Participant who pregnancy, lactating women, and plan to get pregnant within six months after the clinical trial
- Participant who has significant abnormal physical examination, laboratory examination results (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
- Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
- Participant who has drug allergy history, allergy constitution
- Participant who took oral contraceptives within 6 weeks
- Participant who used any drug (including Chinese herbal medicine) within 1 week
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- Participant who donated blood within 2 months
- Participant who participated clinical trials of any drug in the past 3 months (as subjects)
- Participant who has any positive result of virus serology check : human immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) - Immunoglobulin G（IgG)antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP)
- Participant who are smoking, drinking, drinking coffee, strong tea and drug abusers
- Participant who the researchers believe that there are volunteers who are not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site
The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets.
Two panels, each consisting of ten participants (The number of single-sex subjects is not less than 1/3 of the total number) will be randomized to A or B groups.
Read the detailed description
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
- Conditions
- Hypertension
- Being tested
- SPH3127 200mg Panel A, SPH3127 200mg Panel B
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127 200mg Panel ADrug
Also called SPH3127 is a new study drug for hypertension
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
SPH3127 200mg Panel BDrug
Also called SPH3127 is a new study drug for hypertension
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
| Study group | Role | What they receive |
|---|---|---|
| SPH3127 200mg Panel A | Experimental | Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast. Receives: Drug: SPH3127 200mg Panel A |
| SPH3127 200mg Panel B | Experimental | Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis. Receives: Drug: SPH3127 200mg Panel B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma area under curve（AUC）(0-∞) of SPH3127 3127
to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
Measured: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
Plasma Cmax of SPH3127
to evaluate the Cmax of SPH3127 by feeding
Measured: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
Plasma Tmax of SPH3127
to evaluate the Tmax of SPH3127 by feeding
Measured: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
Apparent terminal half-life of SPH3127
to evaluate the Apparent terminal half-life of SPH3127 by feeding
Measured: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127
Measured: Baseline to 10-13 days post last dose
Change from baseline in laboratory hematology values
to evaluate the change from baseline in laboratory hematology values
Measured: Baseline to 10-13 days post last dose
Change from baseline in laboratory chemistry values
to evaluate the Change from baseline in laboratory chemistry values
Measured: Baseline to 10-13 days post last dose
Change from baseline in ECG
to evaluate the from baseline in ECG
Measured: Baseline to 10-13 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start23 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249753
- Sponsor's protocol ID
- SPH3127-103
- Status last verified
- Nov 2021
- First submitted
- 8 Aug 2017
- Last updated
- 15 Nov 2021
- 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 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
- ClinicalTrials.gov ID
- NCT03249753
- Acronym / sponsor ID
- SPH3127-103
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Aug 2017 (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.
This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets.
Two panels, each consisting of ten participants (The number of single-sex subjects is not less than 1/3 of the total number) will be randomized to A or B groups.
Detailed description
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPH3127 200mg Panel A | Experimental | Drug: SPH3127 200mg Panel AParticipants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast. |
| SPH3127 200mg Panel B | Experimental | Drug: SPH3127 200mg Panel BParticipants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The body mass index is 19 ~ 26kg/m2 (including the critical value), which allows the minimum weight of male to be 50kg (including the critical value) and 45kg (the critical value) for women.
- Before the study, participants have kown about the significance, potential benefits, inconveniences and potential risks of the study and can follow the research's procedure and already sign the informed consent
Key exclusion criteria (11 listed)
- Participant who pregnancy, lactating women, and plan to get pregnant within six months after the clinical trial
- Participant who has significant abnormal physical examination, laboratory examination results (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
- Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
- Participant who has drug allergy history, allergy constitution
- Participant who took oral contraceptives within 6 weeks
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 |
|---|---|---|
| SPH3127 200mg Panel AAlso: SPH3127 is a new study drug for hypertensionParticipants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast. | Drug | SPH3127 200mg Panel A |
| SPH3127 200mg Panel BAlso: SPH3127 is a new study drug for hypertensionParticipants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis. | Drug | SPH3127 200mg Panel B |
Primary outcome
Plasma area under curve（AUC）(0-∞) of SPH3127 3127
Time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
Plasma Cmax of SPH3127
Time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Cmax of SPH3127 by feeding
Plasma Tmax of SPH3127
Time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Tmax of SPH3127 by feeding
Apparent terminal half-life of SPH3127
Time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Apparent terminal half-life of SPH3127 by feeding
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Baseline to 10-13 days post last dose
Change from baseline in laboratory hematology values
Time frame: Baseline to 10-13 days post last dose
Change from baseline in laboratory chemistry values
Time frame: Baseline to 10-13 days post last dose
Change from baseline in ECG
Time frame: Baseline to 10-13 days post last dose
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 15 Nov 2021.
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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.
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 SPH3127 200mg Panel A and SPH3127 200mg Panel B in people with Hypertension, run by Shanghai Pharmaceuticals Holding 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 2 inclusion and 11 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 15 Nov 2021. 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?
Plasma area under curve（AUC）(0-∞) of SPH3127 3127 (time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose). The study lists 4 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 15 Nov 2021.