Pharmacokinetics of Neostigmine and Glycopyrrolate (NCT04027972) | Clinical Trial Compass
CompletedEarly Phase 1
Pharmacokinetics of Neostigmine and Glycopyrrolate
United States13 participantsStarted 2020-03-09
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
What they're measuring
1
Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration
Timeframe: Within Two Hours
Trial details
NCT IDNCT04027972
SponsorJames J. Peters Veterans Affairs Medical Center