Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opiate Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test-Reference Sequence

SL spray, followed by SL film

Group Type EXPERIMENTAL

SL spray

Intervention Type DRUG

SL film

Intervention Type DRUG

Reference-Test Sequence

SL film followed by SL spray

Group Type EXPERIMENTAL

SL spray

Intervention Type DRUG

SL film

Intervention Type DRUG

Interventions

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SL spray

Intervention Type DRUG

SL film

Intervention Type DRUG

Other Intervention Names

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Buprenorphine naloxone sublingual spray Buprenorphine and naloxone sublingual film

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes