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

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: SPH3127 200mg Panel B; Drug: SPH3127 200mg Panel A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249753

SPH3127-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SPH3127 200mg Panel A

Experimental group

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.

Treatment:

Drug: SPH3127 200mg Panel A

SPH3127 200mg Panel B

Experimental group

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.

Treatment:

Drug: SPH3127 200mg Panel B