Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/19/2018 |
| Start Date: | May 2014 |
| End Date: | May 2014 |
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK)
of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and
compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg
administered 20 minutes apart.
of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and
compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg
administered 20 minutes 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 supplements or acetaminophen of less than 2 g/day) within 14 days prior
to start of sufentanil dosing prescription medications or over the counter (OTC)
medications
2. Female subjects who are pregnant
3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant
respiratory disorders
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