Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02082236 | Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects | PHASE1 | COMPLETED | 40 | — | — | May 1, 2014 | May 1, 2014 | Jul 17, 2018 | 1 | United States |
Area under the plasma concentration time curve
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute |
| Treatment B | EXPERIMENTAL | Single dose of SSM 30 mcg |
| Treatment C | EXPERIMENTAL | 2 consecutive doses of SSM 15 mcg administered 20 minute apart |
| Treatment D | EXPERIMENTAL | 12 consecutive doses of SSM 30 mcg administered 1 hour apart |
| Name | Type | Description |
|---|---|---|
| Treatment Arm A: Sufenta® | DRUG | Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute |
| Treatment B: Sufentanil SSM 30 mcg | DRUG | single-dose SSM 30 mcg |
| Treatment C: SSM 15 mcg | DRUG | 2 consecutive doses of SSM 15 mcg administered 20 minutes apart |
| Treatment D: SSM 30 mcg | DRUG | 12 consecutive doses of SSM 30 mcg administered 1 hour apart |
Inclusion Criteria: 1. Non-smoking male or female subjects 2. Aged between 18 and 45 years inclusive 3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively. Exclusion Criteria: 1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplem...