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Liraglutide, RD12014

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Sunshine Biopharma Inc.|Last Updated: Mar 24, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Liraglutide, RD12014 · 1 trial · 1 indication

Phase 1 1
NCT05294536A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese SubjectsType 2 Diabetes
COMPLETED50 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum (peak) plasma drug concentration(Cmax)
0 hour(pre-dose,within 30mins) to 72 hours after administration

Maximum (peak) plasma drug concentration

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

The area under the plasma concentration curve from 0 to 72 h

Secondary Endpoints

Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
0 hour(pre-dose,within 30mins) to infinity after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
0 hour(pre-dose,within 30mins) to 72 hours after administration
Elimination half-life (t1/2)
0 hour(pre-dose,within 30mins) to 72 hours after administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Liraglutide injection (RD12014)+ VictozaEXPERIMENTALSubjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.
Victoza + Liraglutide injection (RD12014)EXPERIMENTALSubjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.

Interventions

NameTypeDescription
Liraglutide injection,RD12014DRUGsingle dose, s.c. injection
Liraglutide injection,VictozaDRUGsingle dose, s.c. injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol; * 2\. Aged between 18 and 45 years old of healthy male subjects ; ...

Countries:China
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Frequently asked questions about Liraglutide, RD12014

What is Liraglutide (RD12014) used for?

Liraglutide (RD12014) is a small molecule being developed for Type 2 Diabetes. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being studied for its potential use in managing this metabolic condition.

Who makes Liraglutide (RD12014)?

Liraglutide (RD12014) is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical research on this drug candidate for the treatment of Type 2 Diabetes.

What phase is Liraglutide (RD12014) in?

Liraglutide (RD12014) is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and pharmacokinetic profile in early-stage clinical trials.

What clinical trials is Liraglutide (RD12014) in?

Liraglutide (RD12014) has one completed Phase 1 clinical trial with the identifier NCT05294536. This study was a pharmacokinetic comparison of the Liraglutide injection (RD12014) versus Victoza in healthy Chinese subjects. The trial enrolled 50 male participants and was conducted in China.

Is Liraglutide (RD12014) the same as Victoza?

Liraglutide (RD12014) is being studied as a potential alternative to Victoza, a reference product. A clinical trial compared the pharmacokinetics of the RD12014 injection with Victoza in healthy subjects. However, RD12014 is a separate investigational drug candidate developed by Sunshine Biopharma.

What does the clinical trial for Liraglutide (RD12014) involve?

The completed Phase 1 trial for Liraglutide (RD12014), NCT05294536, was a controlled, randomized, open-label study. It compared the pharmacokinetics of RD12014 with Victoza in 50 healthy Chinese male subjects aged 18 years and older. The trial was conducted in China and focused on healthy volunteers.