Expired Study
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Lenexa, Kansas 66219


Purpose:

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.


Criteria:

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


NCT ID:

NCT01392755


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Lenexa, Kansas 66219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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