The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
- Conditions
- Hypertension
- Interventions
- Drug: SPH3127 200mg Panel BDrug: SPH3127 200mg Panel A
- Registration Number
- NCT03249753
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPH3127 200mg Panel B SPH3127 200mg Panel B 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. SPH3127 200mg Panel A SPH3127 200mg Panel A 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.
- Primary Outcome Measures
Name Time Method Plasma area under curve（AUC）(0-∞) of SPH3127 3127 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
Apparent terminal half-life of SPH3127 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
Plasma Cmax of SPH3127 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 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
- Secondary Outcome Measures
Name Time Method Change from baseline in laboratory hematology values Baseline to 10-13 days post last dose to evaluate the change from baseline in laboratory hematology values
Change from baseline in ECG Baseline to 10-13 days post last dose to evaluate the from baseline in ECG
Change from baseline in laboratory chemistry values Baseline to 10-13 days post last dose to evaluate the Change from baseline in laboratory chemistry values
Number of participants with adverse events (AEs) Baseline to 10-13 days post last dose Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127
Trial Locations
- Locations (1)
The capital medical university affiliated Beijing anzhen hospital
🇨🇳Beijing, Beijing, China