A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/3/2016 |
| Start Date: | July 2011 |
| End Date: | September 2011 |
A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
This randomized, open-label study will evaluate the effect of food, and the effect of
omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be
assigned to one of two treatment groups. Volunteers in both groups will receive oral doses
of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of
omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be
assigned to one of two treatment groups. Volunteers in both groups will receive oral doses
of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of
omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
Inclusion Criteria:
- Adult healthy volunteers, aged 18 to 45 years, inclusive
- Weight >/= 50.0 kg
- Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive
Exclusion Criteria:
- Presence of any active or chronic disease
- Abnormal blood pressure
- Abnormal resting heart rate
- Abnormal ECG values
- History of any clinically significant cardiovascular or cerebrovascular disease
- Current smokers or subjects that have discontinued smoking < 6 months prior to first
dose of study drug
- Positive for hepatitis B, hepatitis C or HIV
- Positive test for drugs of abuse or alcohol
- Positive result for H. pylori
- Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational
drug within 30 days of first dose of study medication
- History of clinically significant gastrointestinal disease
We found this trial at
1
site
Click here to add this to my saved trials
