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Completed

NCT Number: NCT02477267

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • the safety or well-being of the participant or study staff;
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  • the analysis of results

Treatment and study plan

SL spray

Drug

Other names: Buprenorphine naloxone sublingual spray

SL film

Drug

Other names: Buprenorphine and naloxone sublingual film

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

  2. Time to Cmax (Tmax)

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

  3. Elimination rate constant

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

  4. Elimination half-life (T½)

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

  5. Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

  6. Area under the curve extrapolated to infinity (AUCinf)

    Time frame: within 21 days

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

Sponsors and collaborators

Lead sponsor

INSYS Therapeutics Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2015
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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