Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 4/21/2016 |
Start Date: | June 2015 |
End Date: | July 2015 |
A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation
of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®
(buprenorphine and naloxone) sublingual film, under fasted conditions.
of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®
(buprenorphine and naloxone) sublingual film, under fasted conditions.
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of
each treatment period and comply with restrictions related food, drink and
medications
- Voluntarily consents to participate and provides written informed consent prior to
any protocol-specific procedures
Exclusion Criteria:
- Has history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise:
1. the safety or well-being of the participant or study staff;
2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding);
3. the analysis of results
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