Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Generic H/A taken first · 1 trial · 1 indication
"Do you dislike or like the drug effect you are feeling now?" The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with "neither like nor dislike" (score of 50), on the left with "Strong Disliking" (score of 0) and on the right with "Strong Liking" (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
| Arm | Type | Description |
|---|---|---|
| Placebo taken first | PLACEBO_COMPARATOR | Placebo powder snorted with all other arms taken crossover therafter |
| Generic H/A taken first | ACTIVE_COMPARATOR | Generic hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter |
| Vycavert taken first | ACTIVE_COMPARATOR | Vycavert hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter |
| Generic H/A plus i taken first | ACTIVE_COMPARATOR | Generic hydrocodone/APAP 10/325mg plus additional inactive ingredients pulverized tablet snorted with all other arms taken crossover therafter |
| Generic H/A plus p taken first | ACTIVE_COMPARATOR | Generic hydrocodone/APAP 10/325mg plus one placebo pulverized tablet snorted with all other arms taken crossover therafter |
| Name | Type | Description |
|---|---|---|
| Placebo taken first | DRUG | Snorted in both nostrils within 5 minutes; 48 hours washout between doses |
| Generic H/A taken first | DRUG | Snorted in both nostrils within 5 minutes; 48 hours washout between doses |
| Vycavert taken first | DRUG | Snorted in both nostrils within 5 minutes; 48 hours washout between doses |
| Generic H/A plus i taken first | DRUG | Snorted in both nostrils within 5 minutes; 48 hours washout between doses |
| Generic H/A plus p taken first | DRUG | Snorted in both nostrils within 5 minutes; 48 hours washout between doses |
Inclusion Criteria: 1. Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG...