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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03249753
Other study ID # SPH3127-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 23, 2017
Est. completion date September 30, 2018

Study information

Verified date November 2021
Source Shanghai Pharmaceuticals Holding Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China The capital medical university affiliated Beijing anzhen hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma area under curve(AUC)(0-8) of SPH3127 3127 to evaluate the area under curve(AUC)(0-8) 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Change from baseline in ECG to evaluate the from baseline in ECG Baseline to 10-13 days post last dose
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