A Phase 1 Study Comparing AVP-786 With AVP-923
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | March 2015 |
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide
[d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady
state.
[d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady
state.
Inclusion Criteria:
- Healthy adult males or females
- 18 - 60 years of age
- BMI 18 - 32 kg/m2
Exclusion Criteria:
- History or presence of significant disease
- History of substance abuse and/or alcohol abuse with the past 2 years
- Use of tobacco-containing or nicotine-containing products within 6 months
- Use of any prescription or the over-the-counter medications within 14 days
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