NCT06449703

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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®

Timeline

• Start date: 2024-05-06
• Primary completion: 2024-06-16
• Completion: 2024-06-16
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: China