Actively Recruiting
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide in Healthy Chinese Subjects
Led by Tonghua Dongbao Pharmaceutical Co.,Ltd · Updated on 2024-06-10
44
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide in Healthy Chinese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after understanding the study and potential risks
- Able to communicate well and complete the study
- No pregnancy plans and willing to use effective contraception from screening to 6 months after last dose
- Healthy Chinese adults aged 18 to 45 years, male or female
- Body Mass Index between 19 and 26 kg/m2; males weigh at least 50 kg, females weigh at least 45 kg
- Fasting blood glucose less than 6.1 mmol/L at screening
- Physical exam and vital signs normal or abnormal but not clinically significant at screening
You will not qualify if you...
- Allergy to study drug ingredients or GLP-1 analogues, or severe drug/food allergy history
- History of fainting during acupuncture, blood phobia, poor vein condition, or inability to undergo blood collection
- Breastfeeding females or positive pregnancy test at screening
- Participation in drug or device clinical trials within 3 months before screening
- Surgery within 3 months before screening affecting safety or study results, or planned surgery during study
- Blood donation exceeding 400 mL within 3 months before screening or blood transfusion history
- Clinically significant abnormal laboratory tests or diseases in various systems within 12 months before screening
- History of diabetes mellitus
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of pancreatitis
- Past or current thrombotic diseases or use of anticoagulants
- Clinically significant abnormal ECG or calcitonin test at screening
- Positive tests for HIV, hepatitis B or C, or syphilis
- Drug abuse history within 5 years or positive alcohol/drug tests within 3 months before screening
- Smoking more than 5 cigarettes daily within 3 months before screening and unable to quit
- Alcohol intake over 14 units weekly within 3 months before screening and unable to quit
- Excessive caffeine intake (over 8 cups daily) within 3 months before screening and unable to quit
- Use of prescription or non-prescription drugs (except occasional paracetamol), health products (other than vitamins/calcium), or herbal products with unknown components within defined timeframes prior to screening
- Use of any GLP-1 drug within 3 months before screening
- Vaccination within 1 month before screening or planned during study
- Planned strenuous physical activity or exercise during study
- Any other factor making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Hospital of Jilin University
Jilin, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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