Clinical trial NCT03249753: The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
Official title: to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Plasma area under curve（AUC）(0-∞) of SPH3127 3127
timeFrame: 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
measure: Plasma Cmax of SPH3127
timeFrame: 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
measure: Plasma Tmax of SPH3127
timeFrame: 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
measure: Apparent terminal half-life of SPH3127
timeFrame: 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:
measure: Number of participants with adverse events (AEs)
timeFrame: Baseline to 10-13 days post last dose
measure: Change from baseline in laboratory hematology values
timeFrame: Baseline to 10-13 days post last dose
measure: Change from baseline in laboratory chemistry values
timeFrame: Baseline to 10-13 days post last dose
measure: Change from baseline in ECG
timeFrame: Baseline to 10-13 days post last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: The capital medical university affiliated Beijing anzhen hospital
state: Beijing
Study officials:
References: