A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 20
Inclusion Criteria
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
Exclusion Criteria
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Summary
- Conditions
- Diabetes
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
Inclusion Criteria
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
Exclusion Criteria
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Tracking Information
- NCT #
- NCT02089451
- Collaborators
- Not Provided
- Investigators
- Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
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