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The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects

NCT03249753 — Phase 1, Completed, 20 participants, Shanghai Pharmaceuticals Holding Co., Ltd

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to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects

RegistryNCT03249753
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment20 (Actual)
SponsorShanghai Pharmaceuticals Holding Co., Ltd (Industry)
ConditionsHypertension
InterventionsSPH3127 200mg Panel A, SPH3127 200mg Panel B (Drug)
Datesstart 2017-09-23, primary completion 2018-09-30, completion 2018-09-30, first posted 2017-08-15, last updated 2021-11-15
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
SPH3127 200mg Panel AExperimentalDrug: 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 BExperimentalDrug: 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.
  • SPH3127 200mg Panel A (Drug), also known as 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 B (Drug), also known as 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.

+Outcome measures

Primary outcomes

  • 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
  • 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
  • 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

Secondary outcomes

  • 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
  • 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 laboratory chemistry values [Baseline to 10-13 days post last dose]: to evaluate the Change from baseline in laboratory chemistry values
  • Change from baseline in ECG [Baseline to 10-13 days post last dose]: to evaluate the from baseline in ECG

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
The capital medical university affiliated Beijing anzhen hospitalBeijing, Beijing MunicipalityChina

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