drugset / Trial / NCT06449703

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

NCT06449703

Phase 1 Unknown 44 enrolled Tonghua Dongbao Pharmaceutical Co.,Ltd
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2024-05-06
Primary completion
2024-06-16
Completion
2024-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 0.61 mg Subcutaneous
Comparator Xultophy® Unknown
Subject insulin degludec Protein / enzyme biologic 17 iu Subcutaneous

Indications

No indication recorded.