← Back to Search

Anticholinergic

Neostigmine + Glycopyrrolate Pharmacokinetics Study

Phase < 1
Waitlist Available
Led By Mark Korsten, MD
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-70 years
Be older than 18 years old
Must not have
Malignant and/or Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or higher with or without taking 3 or more different classes of anti-hypertensive medications
History of ingrown hair folliculitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 hour of administration
Awards & highlights

Summary

This trial will test how well two drugs, given in two different ways, raise levels of the chemical acetylcholine.

Who is the study for?
This trial is for men and women aged 18-70 without heart or kidney damage, recent strokes, severe low blood pressure, or a history of certain medical conditions. Pregnant or nursing women can't join, nor can VA employees or those with drug sensitivities. Participants must not be in other studies and should pass a cognitive test.
What is being tested?
The study tests how the body processes Neostigmine and Glycopyrrolate when given intravenously and through skin patches (Iontophoresis). It involves healthy volunteers who will have their blood drawn over an hour to track these drugs' presence after administration.
What are the potential side effects?
Possible side effects include reactions at the patch site like skin irritation, as well as potential systemic effects from Neostigmine and Glycopyrrolate such as dry mouth, blurred vision, dizziness, urinary retention, increased heart rate and decreased sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure is 160/100 mmHg or higher, even with medication.
Select...
I have had ingrown hair infections before.
Select...
I feel dizzy or faint when I stand up.
Select...
My MoCA score is above 20, indicating I can make informed decisions.
Select...
I am currently sick with a fever.
Select...
I have had blockages in my digestive or urinary systems.
Select...
My high blood pressure has caused damage to my heart or kidneys, or I've had a stroke.
Select...
I have a history of heart disease or slow heart rate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 hour of administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 hour of administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration
Secondary study objectives
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PrimaryExperimental Treatment2 Interventions
6 Subjects will receive all 4 types of medication administration in random sequence

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,887 Total Patients Enrolled
6 Trials studying Neurogenic Bowel
116 Patients Enrolled for Neurogenic Bowel
Mark Korsten, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
10 Total Patients Enrolled
Christopher P Cardozo, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
3 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Neurogenic Bowel
12 Patients Enrolled for Neurogenic Bowel
~2 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top