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Pharmacokinetics of Neostigmine and Glycopyrrolate

NCT04027972 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-17

No results posted yet for this study

Summary

A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.

Conditions

  • Spinal Cord Injuries
  • Constipation
  • Fecal Incontinence
  • Neurogenic Bowel

Interventions

DRUG

Combination of Neostigmine and Glycopyrrolate

Intravenous or transdermal

DEVICE

I-Box by Dynatronics

Electric field conducting drugs through the skin without compromising its integrity

Sponsors & Collaborators

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Christopher P Cardozo, MD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-09
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027972 on ClinicalTrials.gov