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 Terminal half-life Insulin detemir clearance 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
Novo Nordisk Investigational Site🇨🇳Beijing, Beijing, China