Status:
COMPLETED
Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin i...
Eligibility Criteria
Inclusion
- Male or female, age 18-75 years (both inclusive) at the time of signing inform consent
- Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive)
- A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
- History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
- Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02249910
Start Date
September 18 2014
End Date
March 6 2015
Last Update
February 17 2020
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050