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RECRUITING
NCT06449703
PHASE1

A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide in Healthy Chinese Subjects

Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

View on ClinicalTrials.gov

Summary

The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.

Official title: A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-05-06

Completion Date

2024-06-16

Last Updated

2024-06-10

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

insulin degludec/liraglutide

Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the abdomen.

DRUG

Xultophy®

Xultophy®

Locations (1)

the First Hospital of Jilin University

Jilin, China