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Trial record 17 of 56 for:    insys

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 22, 2015
Last Update Posted Date September 3, 2015
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2015)
  • Maximum plasma concentration (Cmax) [ Time Frame: within 21 days ]
    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
  • Time to Cmax (Tmax) [ Time Frame: within 21 days ]
    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
  • Elimination rate constant [ Time Frame: within 21 days ]
    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
  • Elimination half-life (T½) [ Time Frame: within 21 days ]
    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
  • 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
  • Area under the curve extrapolated to infinity (AUCinf) [ Time Frame: within 21 days ]
    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02477267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Opiate Dependence
Intervention  ICMJE
  • Drug: SL spray
    Other Name: Buprenorphine naloxone sublingual spray
  • Drug: SL film
    Other Name: Buprenorphine and naloxone sublingual film
Study Arms  ICMJE
  • Experimental: Test-Reference Sequence
    SL spray, followed by SL film
    Interventions:
    • Drug: SL spray
    • Drug: SL film
  • Experimental: Reference-Test Sequence
    SL film followed by SL spray
    Interventions:
    • Drug: SL spray
    • Drug: SL film
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2015)
24
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02477267
Other Study ID Numbers  ICMJE INS009-15-033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP