| Trial ID: | L6434 |
| Source ID: | NCT03199261
|
| Associated Drug: |
Re-4 Injection
|
| Title: |
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: rE-4 Injection|DRUG: rE-4 Freeze-dried Powder
|
| Outcome Measures: |
Primary: Bioequivalency between the 2 formulations of rE-4, Area under curve, before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection |
|
| Sponsor/Collaborators: |
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-12-23
|
| Completion Date: |
2017-01-21
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-26
|
| Locations: |
The Affiliated Hospital Military Medical Sciences, Beijing, 100071, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03199261
|
