Status:
COMPLETED
Pharmacokinetics of Neostigmine and Glycopyrrolate
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Spinal Cord Injuries
Constipation
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
The maximum dose of NEO is limited to 10.0 mg and the dose of GLY to 2.0 mg per subject per administration. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A...
Eligibility Criteria
Inclusion
- Male or Female
- Age 18-70 years
Exclusion
- Previous adverse reaction or hypersensitivity to electrical stimulation,
- Known sensitivity to neostigmine or glycopyrrolate,
- History of mechanical obstruction of the GI or urinary tract,
- Myocardial infarction within 6 months of trial,
- 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,
- Organ damage (heart \& kidney) and/or TIA-CVA as a result of hypertension,
- Known past history of coronary artery disease or bradyarrhythmia,
- Symptomatic orthostatic hypotension
- Deep brain stimulation
- Pregnancy (women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of the study),
- Lactating, nursing females
- Inability to provide informed consent signaled by MoCA cognitive test score of 20 or less,
- History of ingrown hair folliculitis,
- Concurrent illness and fever,
- Concurrent participation in a research study,
- VA employee.
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04027972
Start Date
March 9 2020
End Date
December 20 2022
Last Update
September 17 2025
Active Locations (1)
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1
James J Peters VA Medical Center
The Bronx, New York, United States, 10468