Overview
A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2011-09-01
2011-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Citalopram
Dexetimide
Lactams
Ritonavir
Criteria
Inclusion Criteria:- Adult healthy volunteers, aged 18 to 55 years, inclusive
- Body mass index (BMI) 18.0 to 32.0 kg, inclusive
- Absence of evidence of any active or chronic disease
- Non-smokers
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