Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pharmacokinetics
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 30 years
- Gender
- Both males and females
Description
In this clinical study, we will evaluate the plasma pharmacokinetics of amiloride nasal spray in healthy volunteers at three different doses. The data obtained from this study will provide us with pharmacokinetic information that will help develop dosing regimens for future clinical efficacy studies...
In this clinical study, we will evaluate the plasma pharmacokinetics of amiloride nasal spray in healthy volunteers at three different doses. The data obtained from this study will provide us with pharmacokinetic information that will help develop dosing regimens for future clinical efficacy studies in anxiety patients. Currently, there is no information on the bioavailability and pharmacokinetics of amiloride in humans after intranasal administration. All participants will be allowed to self-administer amiloride nasal spray at 0.2, 0.4, and 0.6 mg doses of amiloride. A series of timed blood samples (0,10, 15, 30, 60 minutes, and 4, 6, 8, 12 and 24 hours,1mL each time point) will be collected. Primary objectives: To evaluate the pharmacokinetics of amiloride nasal spray at three different doses 0.2, 0.4, and 0.6 mg in healthy human volunteers. To calculate the following pharmacokinetic parameters after intranasal administration of amiloride: time to reach maximum plasma concentration (Tmax), maximum plasma concentration (Cmax), area under the curve (AUC), the volume of distribution (Vd) and clearance (CL).
Tracking Information
- NCT #
- NCT04181008
- Collaborators
- Center for Addiction and Mental Health
- Investigators
- Principal Investigator: Venkata K Yellepeddi, PhD University of Utah