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Clinical Trial Details

Trial ID: L4227
Source ID: NCT01650324
Associated Drug: Dbpr108
Title: A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01650324/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, There were 4 mild adverse events observed during the course of study., Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7. | Secondary: Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity), Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups., predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax), Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups., predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax), Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups., predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose, Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min., predose (0 hr) and 48 hrs post dose
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: 2012-07
Completion Date: 2012-12
Results First Posted: 2014-08-28
Last Update Posted: 2014-08-28
Locations: Taipei Medical University - Wanfang Hospital, Taipei, 116, Taiwan
URL: https://clinicaltrials.gov/show/NCT01650324