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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SPH3127 200mg Panel A
SPH3127 200mg Panel B
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The capital medical university affiliated Beijing anzhen hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SPH3127 200mg Panel A

SPH3127 200mg Panel B

Arm 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.

Outcomes

Primary Outcome Measures

Plasma area under curve（AUC）(0-∞) of SPH3127 3127
to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
Plasma Cmax of SPH3127
to evaluate the Cmax of SPH3127 by feeding
Plasma Tmax of SPH3127
to evaluate the Tmax of SPH3127 by feeding
Apparent terminal half-life of SPH3127
to evaluate the Apparent terminal half-life of SPH3127 by feeding

Secondary Outcome Measures

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
Change from baseline in laboratory hematology values
to evaluate the change from baseline in laboratory hematology values
Change from baseline in laboratory chemistry values
to evaluate the Change from baseline in laboratory chemistry values
Change from baseline in ECG
to evaluate the from baseline in ECG

Full Information

First Posted
August 8, 2017
Last Updated
November 11, 2021
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03249753
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPH3127 200mg Panel A
Arm Type
Experimental
Arm 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.
Arm Title
SPH3127 200mg Panel B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SPH3127 200mg Panel A
Other Intervention Name(s)
SPH3127 is a new study drug for hypertension
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
SPH3127 200mg Panel B
Other Intervention Name(s)
SPH3127 is a new study drug for hypertension
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma area under curve（AUC）(0-∞) of SPH3127 3127
Description
to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
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
Title
Plasma Cmax of SPH3127
Description
to evaluate the Cmax of SPH3127 by feeding
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
Title
Plasma Tmax of SPH3127
Description
to evaluate the Tmax of SPH3127 by feeding
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
Title
Apparent terminal half-life of SPH3127
Description
to evaluate the Apparent terminal half-life of SPH3127 by feeding
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
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127
Time Frame
Baseline to 10-13 days post last dose
Title
Change from baseline in laboratory hematology values
Description
to evaluate the change from baseline in laboratory hematology values
Time Frame
Baseline to 10-13 days post last dose
Title
Change from baseline in laboratory chemistry values
Description
to evaluate the Change from baseline in laboratory chemistry values
Time Frame
Baseline to 10-13 days post last dose
Title
Change from baseline in ECG
Description
to evaluate the from baseline in ECG
Time Frame
Baseline to 10-13 days post last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The capital medical university affiliated Beijing anzhen hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

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

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