Status:
COMPLETED
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formu...
Eligibility Criteria
Inclusion
- Age 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as informed consent
- Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
Key Trial Info
Start Date :
November 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02304627
Start Date
November 24 2014
End Date
July 31 2015
Last Update
July 8 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460