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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: SPH3127 200mg Panel A; Drug: SPH3127 200mg Panel B

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • The capital medical university affiliated Beijing anzhen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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.; Other Names: SPH3127 is a new study drug for hypertension
EXPERIMENTAL: 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.	Drug: 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.; Other Names: SPH3127 is a new study drug for hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma area under curve（AUC）(0-∞) of SPH3127 3127	to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding	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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline to 10-13 days post last dose
Change from baseline in ECG	to evaluate the from baseline in ECG	Baseline to 10-13 days post last dose

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2017
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: SPH3127-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No