The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers
NCT ID: NCT02361138
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2013-12-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
NCT02356224
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients
NCT02366351
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
NCT02346175
Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes
NCT03159052
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients
NCT02366377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort SHR3824/Placebo 1.25 mg
SHR3824 1.25 mg/day or placebo for 10 days.
SHR3824
Placebo
Cohort SHR3824/Placebo 2.5 mg
SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
SHR3824
Placebo
Cohort SHR3824/Placebo 5 mg
SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
SHR3824
Placebo
Cohort SHR3824/Placebo 10 mg
SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
SHR3824
Placebo
Cohort SHR3824/Placebo 25 mg
SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
SHR3824
Placebo
Cohort SHR3824/Placebo 100mg
SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
SHR3824
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR3824
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI:18 -25 kg/m2.
* Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.
Exclusion Criteria
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
* Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
* Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR3824-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.