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Completed

NCT Number: NCT03249753

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SPH3127 is a new study drug for hypertension

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.

Other names: SPH3127 is a new study drug for hypertension

Primary outcomes

  1. Plasma area under curve（AUC）(0-∞) of SPH3127 3127

    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

    to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding

  2. Plasma Cmax of SPH3127

    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

    to evaluate the Cmax of SPH3127 by feeding

  3. Plasma Tmax of SPH3127

    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

    to evaluate the Tmax of SPH3127 by feeding

  4. Apparent terminal half-life of SPH3127

    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

    to evaluate the Apparent terminal half-life of SPH3127 by feeding

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: 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

  2. Change from baseline in laboratory hematology values

    Time frame: Baseline to 10-13 days post last dose

    to evaluate the change from baseline in laboratory hematology values

  3. Change from baseline in laboratory chemistry values

    Time frame: Baseline to 10-13 days post last dose

    to evaluate the Change from baseline in laboratory chemistry values

  4. Change from baseline in ECG

    Time frame: Baseline to 10-13 days post last dose

    to evaluate the from baseline in ECG

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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