A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | August 2011 |
| End Date: | September 2011 |
A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects
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.
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.
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
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