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

NCT03249753 | Completed Phase 1

• 1 other identifier: SPH3127-103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of participants with adverse events (AEs)

  Baseline to 10-13 days post last dose

• Change from baseline in laboratory hematology values

  Baseline to 10-13 days post last dose

• Change from baseline in laboratory chemistry values

  Baseline to 10-13 days post last dose

• Change from baseline in ECG

  Baseline to 10-13 days post last dose

Study Arms (2)

SPH3127 200mg Panel A

EXPERIMENTAL

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

SPH3127 200mg Panel B

EXPERIMENTAL

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

Interventions

SPH3127 200mg Panel A DRUG

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.

Also known as: SPH3127 is a new study drug for hypertension

SPH3127 200mg Panel A

SPH3127 200mg Panel B DRUG

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.

Also known as: SPH3127 is a new study drug for hypertension

SPH3127 200mg Panel B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

SPH3127

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: September 23, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

CN (1)