Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/15/2016 |
| Start Date: | March 2015 |
| End Date: | July 2015 |
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor,
itraconazole, on the steady-state PK of AVP-923 and AVP-786.
itraconazole, on the steady-state PK of AVP-923 and AVP-786.
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
Inclusion Criteria:
- Healthy adult males and females, 18 to 55 years of age
- Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
Exclusion Criteria:
- History or presence of significant disease
- History of substance abuse or dependence (except caffeine), or treatment for
substance use disorder(s) within the year prior to screening or within 6 months for
nicotine including e-cigarettes
- Use of any tobacco-containing or nicotine-containing products within 6 months prior
to the first dose
- Use of any prescription or the over-the-counter medications within 14 days
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