| Trial ID: | L4211 |
| Source ID: | NCT02356224
|
| Associated Drug: |
Shr3824
|
| Title: |
The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
|
| Acronym: |
SHR3824
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SHR3824|DRUG: Placebo
|
| Outcome Measures: |
Primary: Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect., 24h after dosing|SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics., Up to 72h after dosing | Secondary: The number of patients with adverse events as a measure of safety and tolerability, up to day 72h after dosing
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
84
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-05
|
| Locations: |
Shanghai Xuhui Central Hospital, Shanghai, Shanghai, 200031, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02356224
|
