Study S001458

A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers

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: NCT05294536
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 50
Start: 2020-06-22
Primary completion: 2020-07-20
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:Liraglutide injection,RD12014; DRUG:Liraglutide injection,Victoza
Results posted: FALSE

Registered primary outcomes

Maximum (peak) plasma drug concentration(Cmax) [0 hour（pre-dose,within 30mins） to 72 hours after administration]
Area under the plasma concentration-time curve from time zero to time t (AUC0-t) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0015698	A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Zhou R, Clinical and translational science	2022	Randomized trial	PMID 35871497 DOI	cites ClinicalTrials.gov:NCT05294536; registry reference DERIVED:35871497