Human Bioequivalence Test of Liraglutide Injection

Registration

Registration

NCT05029076

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

28

Start

2019-05-21

Primary completion

2019-06-01

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Conditions

Type 2 Diabetes

Interventions

DRUG:Liraglutide injection; DRUG:Victoza

Results posted

FALSE

Registered primary outcomes

• Maximum (peak) plasma drug concentration(Cmax) [0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.]
• Time to reach maximum (peak) plasma concentration following drug administration (Tmax) [0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.]
• Area under the plasma concentration-time curve from time zero to time t (AUC0-t) [0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.]
• Terminal disposition rate constant/terminal rate constant (λz) [0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.]
• Elimination half-life (t1/2) [0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.]
• Apparent total clearance of the drug from plasma after oral administration (CL/F) [0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.]
• Apparent volume of distribution after non-intravenous administration (Vd/F) [0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.]
• Bioavailability (systemic availability of the administered dose) [0 hour（pre-dose, within 60mins） to 72 hours after administration on day1 and day 15.]
• Adverse Event, Serious Adverse Event and Drug Combination [up to day 15]