Study S000924

The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT03199261
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 24
Start: 2016-12-23
Primary completion: 2017-01-21
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:rE-4 Injection; DRUG:rE-4 Freeze-dried Powder
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Bioequivalency between the 2 formulations of rE-4 [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]

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