Clinical Trial Details
| Trial ID: | L5205 |
| Source ID: | NCT02467790 |
| Associated Drug: | Pex168 |
| Title: | Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: PEX168 |
| Outcome Measures: | Primary: Pharmacokinetic index, Prior to administration (within 60 minutes, recorded as 0h) and after administration 24h (Day 2), 48h (Day 3), 72h (day 4), 96h (day 5), 120h (day 6 ), 144h (day 7), 216h (day 10), 312h (day 14 ), 480h (day 21), 648h (day 28), 720h (day 31) collect blood 3 ml and test serum concentrations of PEX168., Baseline to Day31 | Secondary: Incidence of adverse events and serious adverse events, Baseline to Day31 |
| Sponsor/Collaborators: | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2015-02 |
| Completion Date: | 2016-05 |
| Results First Posted: | |
| Last Update Posted: | 2016-01-26 |
| Locations: | Third Xiangya Hospital, Central South Univety, Chang Sha, Hunan, China |
| URL: | https://clinicaltrials.gov/show/NCT02467790 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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