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Clinical Trials/NCT01639729
NCT01639729CompletedPhase 1

Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Talphera, Inc2 sites in 1 country25 target enrollmentStarted: July 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Tmax
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •body mass index 18 - 30

Exclusion Criteria

  • •pregnant females
  • •pulmonary disease
  • •sleep apnea

Outcomes

Primary Outcomes

Tmax

Time Frame: 24 hours

time to maximum plasma concentration

AUC (0 - Inf)

Time Frame: 24 hours

total amount of sufentanil absorbed

Cmax

Time Frame: 24 hours

maximum plasma concentration

CST 1/2

Time Frame: 24 hours

time for maximum plasma concentration to decrease by 50%

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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