Status:
COMPLETED
The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in heal...
Detailed Description
Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the f...
Eligibility Criteria
Inclusion
- The body mass index is 18-28kg/m2 (including the critical value), which allows the minimum weight of men to be 50kg (including the critical value) and 45kg for women (including the critical value).
- Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
- Participant has understood the research's procedure and sign the informed consent .
Exclusion
- Participant who are Pregnancy, lactating women, and planned trials begin within six months of pregnancy
- Participant who has abnormal Physical examination, laboratory examination results and clinical significance (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 and anaphylactic reaction
- Participant who took oral contraceptive in 6 months
- 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 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 used to smoke, alcohol abuse, eat coffee and strong tea and drug abuse
- Participant who the researchers believe that there are volunteers who are not suitable for the study
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03255993
Start Date
October 23 2017
End Date
September 20 2018
Last Update
November 15 2021
Active Locations (1)
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1
The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, China, 100029