Sublingual vs IV Atropine Bioavailability Study
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Toxic Effect of Organophosphate and Carbamate Insecticides
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This is a randomized, three-sequence, three-period crossover study to assess the bioavailability and PK of a single dose of atropine administered sublingually in healthy adult volunteers. At least 15 healthy male and female volunteers will be enrolled to obtain approximately 12 evaluable subjects in...
This is a randomized, three-sequence, three-period crossover study to assess the bioavailability and PK of a single dose of atropine administered sublingually in healthy adult volunteers. At least 15 healthy male and female volunteers will be enrolled to obtain approximately 12 evaluable subjects in the per protocol population. Eligible subjects will be randomized at a 1:1:1 ratio to receive one of three treatment dosing sequences (A, B, or C).
Tracking Information
- NCT #
- NCT04290039
- Collaborators
- Rho, Inc.
- Investigators
- Study Chair: Michael Schwartz, MD MPH Department of Health and Human Services
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