Status:
COMPLETED
Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide 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 omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healt...
Eligibility Criteria
Inclusion
- Male or female age 18-75 years (both inclusive) at time of signing informed consent
- Body mass index of 18.5-29.9 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 or equal to 140 mmHg and/or diastolic blood pressure above or equal to 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 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02249871
Start Date
September 24 2014
End Date
April 1 2015
Last Update
August 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Berlin, Germany, 14050