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Clinical Trial Details

Trial ID: L6529
Source ID: NCT02163278
Associated Drug: Dbpr108
Title: A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: DBPR108|DRUG: matching placebo
Outcome Measures: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability, Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks | Secondary: Pharmacokinetic parameters, PK parameters are including: Cmax, Cmin, Cavg, Cmin,i , Tmax, Tlast, t1/2, AUCτ, AUC0-t, AUC0-inf, % Fluctuation, Apparent body clearance following extravascular dosing (CL/F), Vz/F, Aet1-t2, Ae0-t, fe0-t, Renal clearance (CLR), Accumulation index (AI) and Accumulation ration (AR), 33 time points during 12 days (including measurements before dosing)|Pharmacodynamic parameters, PD parameters are including: Emax, Emin, Time to maximum effect (TEmax), TEmin, Area under the response versus time curve during a dosing interval ( AUECτ) and Area under the response versus time curve from time zero to the time of last quantifiable response (AUEC0-t), 34 time points during 10 days (including measurements before dosing)
Sponsor/Collaborators: Sponsor: National Health Research Institutes, Taiwan
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2015-01
Results First Posted:
Last Update Posted: 2016-03-28
Locations: Taipei Medical University - Taipei Medical University Hospital, Taipei, 11031, Taiwan
URL: https://clinicaltrials.gov/show/NCT02163278