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Trial record 17 of 56 for:    insys

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

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ClinicalTrials.gov Identifier: NCT02477267
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: SL spray Drug: SL film Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : June 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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Arm Intervention/treatment
Experimental: Test-Reference Sequence
SL spray, followed by SL film
Drug: SL spray
Other Name: Buprenorphine naloxone sublingual spray

Drug: SL film
Other Name: Buprenorphine and naloxone sublingual film

Experimental: Reference-Test Sequence
SL film followed by SL spray
Drug: SL spray
Other Name: Buprenorphine naloxone sublingual spray

Drug: SL film
Other Name: Buprenorphine and naloxone sublingual film




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477267


Locations
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United States, Texas
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Giovanni DeCastro INSYS Therapeutics Inc

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02477267     History of Changes
Other Study ID Numbers: INS009-15-033
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists