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

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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.


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
We found this trial at
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San Antonio, TX
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