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

INSYS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Opiate Dependence

Treatments: Drug: SL film; Drug: SL spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477267

INS009-15-033

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Test-Reference Sequence

Experimental group

Description:

SL spray, followed by SL film

Treatment:

Drug: SL spray

Drug: SL film

Reference-Test Sequence

Experimental group

Description:

SL film followed by SL spray

Treatment:

Drug: SL spray

Drug: SL film