Pharmacokinetics of Neostigmine and Glycopyrrolate After Intravenous and Transcutaneous Administration by Iontophoresis

KOR-18-16

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.

2020-03-09

2023-02-17

2024-09-28

Active (not recruiting)

Early phase I

13

Inclusion Criteria: * Male or Female * Age 18-70 years Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Same group receives all 2 treatments but in a randomized order after the IV phase.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

2023-10-12