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

Sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study ID
NCT06449703
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • insulin degludec/liraglutide — DRUG
    Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the abdomen.
  • Xultophy® — DRUG
    Xultophy®

Study Details

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.

Key Dates

Start date
May 6, 2024
Status verified
May 2024
Primary completion
Jun 16, 2024
Completion
Jun 16, 2024

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin Degludec/Liraglutide
  • Active Comparator: Xultophy®

Primary Outcome Measure

Maximum observed plasma insulin degludec concentration [ Time Frame: 0 hours to 120 hours ]

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