Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects
- Registration Number
- NCT01498939
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)
- Fasting plasma glucose maximum 6 mmol/L
- Non-smoker
- Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator
Exclusion Criteria
- Known or suspected allergy to trial product(s) or related products
- Previous participation in this trial. Participation is defined as randomisation
- Receipt of any investigational drug within the last three months prior to this trial
- History of alcohol or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IDet 0.2 U/kg insulin detemir - IDet 0.4 U/kg insulin detemir - IDet 0.8 U/kg insulin detemir -
- Primary Outcome Measures
Name Time Method Area under the insulin detemir concentration curve from time zero to 24 hour
- Secondary Outcome Measures
Name Time Method Insulin detemir clearance Terminal half-life Area under the insulin detemir concentration curve Maximum serum insulin detemir concentration Time to maximum serum insulin detemir concentration Mean residence time (MRT) Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇳Beijing, Beijing, China