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Clinical Trial Details

Trial ID: L4092
Source ID: NCT01952535
Associated Drug: Hms5552
Title: A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: HMS5552|DRUG: Placebo
Outcome Measures: Primary: Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements., up to 72 hours post-dose | Secondary: The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2., Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose., up to 72 hours post-dose|Pharmacodynamic variables will include maximum change (%) in fasting plasma glucose level, AUC0-4 of fasting plasma glucose , AUC of percent reduction in fasting plasma glucose from baseline versus time curve, time of minimum glucose level, up to 6 hours post-dose
Sponsor/Collaborators: Sponsor: Hua Medicine Limited
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2013-12
Results First Posted:
Last Update Posted: 2017-11-20
Locations: Hua Medicine Limited, Shanghai, Shanghai, 201203, China
URL: https://clinicaltrials.gov/show/NCT01952535