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Trial · NCT03179891

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Tmax Pharmacokinetic EndPointsInterictal State1.000Full Range 0.249 to 4.017hours
Tmax Pharmacokinetic EndPointsIctal/Peri-ictal State0.525Full Range 0.250 to 2.033hours
Cmax Pharmacokinetic EndPointsInterictal State230.32Standard Deviation 89.00ng/mL
Cmax Pharmacokinetic EndPointsIctal/Peri-ictal State209.49Standard Deviation 120.18ng/mL
Area Under the Plasma Concentration Curve Pharmacokinetic EndPointsInterictal State560.18Standard Deviation 219.70h*ng/mL
Area Under the Plasma Concentration Curve Pharmacokinetic EndPointsIctal/Peri-ictal State498.78Standard Deviation 319.09h*ng/mL
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First AttemptInterictal StateUnsuccessful insertion/placement0Participants
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First AttemptIctal/Peri-ictal StateUnsuccessful insertion/placement2Participants
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First AttemptInterictal StateSuccessful insertion/placement33Participants
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First AttemptIctal/Peri-ictal StateSuccessful insertion/placement31Participants
Usability Endpoint: Swallowing the Film Before Complete Disintegration/DissolutionInterictal StateYes-DBF was Swallowed4Participants
Usability Endpoint: Swallowing the Film Before Complete Disintegration/DissolutionIctal/Peri-ictal StateYes-DBF was Swallowed2Participants
Usability Endpoint: Swallowing the Film Before Complete Disintegration/DissolutionInterictal StateNo-DBF was not Swallowed29Participants
Usability Endpoint: Swallowing the Film Before Complete Disintegration/DissolutionIctal/Peri-ictal StateNo-DBF was not Swallowed31Participants
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete DisintegrationInterictal StateYes-DBF was spit out/blown out0Participants
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete DisintegrationIctal/Peri-ictal StateYes-DBF was spit out/blown out3Participants
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete DisintegrationInterictal StateNo-DBF was not spit out/blown out33Participants
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete DisintegrationIctal/Peri-ictal StateNo-DBF was not spit out/blown out30Participants
Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal MucosaInterictal StateYes, saliva exited the mouth0Participants
Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal MucosaIctal/Peri-ictal StateYes, saliva exited the mouth2Participants

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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